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St. Jude Medical Amplatzer, Инструкция по эксплуатации

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11

Directions for Use

Materials recommended for use with the device

• The AMPLATZER™ 45° Delivery System or the AMPLATZER™ TorqVue™ 45° Delivery 

System (both sold separately) is recommended for use with the AMPLATZER™ Septal 
Occluder.

• 0.035-inch exchange-length J-tip guidewire
• AMPLATZER™ Sizing Balloon II

Preprocedure Care

It is recommended that at least 24 hours prior to the procedure that the patient receives aspirin 
(81 mg or 325 mg) or an alternative antiplatelet/anticoagulant if the patient has an aspirin 
intolerance. 

Procedure

 1.   Prepare the patient for a standard transcatheter procedure. Maintain a recommended 

activated clotting time (ACT) of greater than 200 seconds. Effective anticoagulation 
therapy should be maintained during and after the procedure as determined by the 
physician.

2. Puncture the femoral vein and perform a standard right-heart catheterization.
3. Perform an angiogram to demonstrate the atrial defect. Catheterize the left atrium using a 

45º LAO position and cranial angulation of 35º–45º. Inject contrast medium into the right 
upper lobe pulmonary vein.

Note: Occluder size and placement are based on the locations of the defects. 

4. Use the J-tip guidewire to gain access to the left atrium.
5. Echo guidance: The procedure should be performed under echo guidance to allow for 

comprehensive assessment of all rims (with specific emphasis on adequacy of the 
anterior-superior rim) and cardiac structures to enable appropriate placement and 
position of the ASD device, and to assess whether acute ASD closure has been achieved 
without pathologic interference or impingement on important surrounding cardiac 
structures. Use echocardiographic measurements and an AMPLATZER™ Sizing 
Balloon II to determine the diameter of the defect. Refer to the instructions for use 
included with the AMPLATZER™ Sizing Balloon II for more information. 

Note: If balloon sizing is performed in addition to echocardiographic measurements, a 

stop-flow technique should be used.

6. Insert a compliant balloon catheter over the guidewire into the left atrium and determine 

the diameter of the defect.
- Under fluoroscopic and echocardiographic guidance, place the balloon catheter across 

the defect and inflate the balloon with diluted contrast medium until the left-to-right 
shunt ceases. 

- Deflate the balloon until flow is visible, and then reinflate the balloon until the shunting 

ceases. 

WARNING: Do not inflate the balloon beyond the stop-flow point or beyond the balloon's 
maximum inflation volume. Inflation beyond the stop-flow point may cause distention of 
the defect (resulting in inaccurate sizing of the defect) and/or balloon damage.

Note: A waist in the balloon could appear without the cessation of flow. This would occur if 

there is more than one ASD. Sizing should occur based on stop-flow, not the appearance 

of a waist.

- Measure the defect using echocardiographic imaging, fluoroscopy, or by using the 

AMPLATZER™ Sizing Plate.

7. Once the diameter of the defect is determined, select a device size equal to or 1 size 

larger than the diameter of the defect. Refer to Table  T1 on the foldout of the back cover.
WARNING: Do not select a device size that is more than 1.5 times the 
echocardiographic-derived ASD diameter prior to balloon sizing.

8. Remove the balloon catheter and leave the guidewire in place.

100092311_ASD.book  Page 11  Monday, January 6, 2014  11:00 AM

Содержание Amplatzer

Страница 1: ...ros okliuderis Naudojimo instrukcija sq Okludues septal Udhëzime për përdorim el Συσκευή απόφραξης διαφράγματος Οδηγίες χρήσης lv Starpsienas Nosprostotājs Lietošanas instrukcija sr Septalni okluder Uputstvo za upotrebu es Oclusor septal Instrucciones de uso nl Septale occluder Gebruiksaanwijzing sv Anordning för slutning av septum Bruksanvisning et Vaheseina sulgur Kasutusjuhend no Septal lukkean...

Страница 2: ...atsparus MR Drošs lietošanai ar MR noteiktos apstākļos MR veilig onder bepaalde voorwaarden MR sikker under visse betingelser Warunkowe użycie z MR Condicional para RM Acceptat MR în anumite condiţii Условно пригодно для использования в МР окружении Podmienky vystavenia MR Pogojna uporaba z magnetno resonanco MR Kushtëzimi nga MR ja Uslovno bezbedno u MR okruženju MR säker under vissa betingelser ...

Страница 3: ...als de verpakking is beschadigd Må ikke brukes hvis pakken er skadet Nie używać jeżeli opakowanie jest uszkodzone Não usar se a embalagem estiver danificada Nu utilizaţi dacă ambalajul este deteriorat Не использовать если упаковка повреждена Nepoužívajte ak je obal poškodený Ne uporabljajte če je embalaža poškodovana Mos e përdorni nëse është dëmtuar ambalazhi Ne koristiti ako je pakovanje oštećen...

Страница 4: ...다 Federalinis įstatymas JAV leidžia pardavinėti šiuos įtaisus tik gydytojams ar tinkamai licencijuotiems praktikams arba jų nurodymu Saskaņā ar ASV federālo likumu šo ierīci drīkst pārdot tikai ārstiem un atbilstoši licencētiem medicīnas darbiniekiem vai abu minēto kategoriju pilnvarotām personām Volgens de Amerikaanse wetgeving mag dit hulpmiddel alleen door of op voorschrift van een arts of gedi...

Страница 5: ...oni per l uso 102 ko 사용 설명서 109 lt Naudojimo instrukcija 115 lv Lietošanas instrukcija 122 nl Gebruiksaanwijzing 129 no Bruksanvisning 136 pl Instrukcja użytkowania 143 pt Instruções de Utilização 151 ro Instrucţiuni pentru utilizare 158 ru Инструкции по применению 165 sk Návod na použitie 173 sl Navodila za uporabo 180 sq Udhëzime për përdorim 187 sr Uputstvo za upotrebu 194 sv Bruksanvisning 201...

Страница 6: ...ndications and Usage The AMPLATZER Septal Occluder is a percutaneous transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects ASDs in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial ...

Страница 7: ...ient data including inadequate echocardiographic information about the cases already reported to determine etiology of erosion Do not select a device size larger than 1 5 times the ASD diameter measured by echocardiography before balloon sizing Do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if ...

Страница 8: ...20 G cm or less Maximum MR system reported whole body averaged specific absorption rate SAR of 3 W kg for 15 minutes of scanning During testing the device produced a clinically non significant temperature rise at a maximum MR system reported whole body averaged specific absorption rate SAR of 3 W kg for 15 minutes of scanning in a 3 tesla MR system using a transmit receive body coil MR image quali...

Страница 9: ...t block hematoma pseudoaneurysm including blood loss requiring transfusion hemolysis hypertension hypotension infection myocardial infarction perforation pericardial effusion peripheral embolism peripheral pulse loss phrenic nerve injury pleural effusion residual shunt stroke transient ischemic attack thromboembolic event thrombus formation embolization tissue trauma damage valve damage valvular i...

Страница 10: ...ent 2 442 0 5 0 154 0 0 1 00 Device embolization with surgical removal 3 442 0 7 0 154 0 0 0 57 Device embolization with percutaneous removal 1 442 0 2 0 154 0 0 1 00 Delivery system failure 1 442 0 2 0 154 0 0 1 00 Pericardial effusion with tamponade 0 442 0 0 3 154 1 9 0 017 Pulmonary edema 0 442 0 0 1 154 0 6 0 26 Repeat surgery 0 442 0 0 2 154 1 3 0 066 Surgical wound adverse events 0 442 0 0 ...

Страница 11: ...um primum or sinus venosus atrial septal defects Partial anomalous pulmonary venous drainage Pulmonary vascular resistance above 7 Woods units or a right to left shunt at the atrial level with a peripheral arterial saturation less than 94 Patients with recent myocardial infarction unstable angina and decompensated congestive heart failure Patient with right and or left ventricular decompensation w...

Страница 12: ...line Demographics Variable AMPLATZER Patients Surgical Control Patients p value Age years Mean s d N 18 1 19 3 442 5 9 6 2 154 0 001 range 0 6 82 0 0 6 38 2 Gender Female 299 442 67 6 94 154 61 0 0 14 Male 143 442 32 4 60 154 39 0 Height cm Mean s d N 134 6 32 0 440 105 5 26 9 151 0 001 range 58 188 60 178 Weight kg Mean s d N 42 3 27 3 440 20 6 15 2 153 0 001 range 6 3 130 4 8 78 4 Medical Histor...

Страница 13: ...monary bypass aortic cross clamp and right atriotomy If the defect is small primary repair by suturing the defect is feasible however if the defect is large then patch closure is the preferred method Different surgeons use different material for the patch Most surgeons use pericardium however some surgeons use GORE TEX to repair the ASD At the end of the operation the surgeon inserts chest tubes t...

Страница 14: ...ar access site adverse events retroperitoneal hematoma surgical wound adverse events other procedural adverse events pericardial effusion requiring medical management evidence of device associated thrombus formation without embolization with or without treatment and marker band embolization without known sequelae Table 5 Principal Effectiveness and Safety Results Pivotal Study AMPLATZER Patientsa ...

Страница 15: ...49 4 7 0 086 0 008 Minor Adverse Events 12 months 16 328 4 9 29 149 19 5 0 221 0 085 12 month Composite Success K M 0 930 0 944 0 055 0 027 Survival at 30 days K M 0 933 0 954 0 059 0 017 Survival at 180 days K M 0 930 0 954 0 062 0 014 Table 7 Principal Efficacy Results Fenestrated Fontan AMPLATZER Patients Upper 95 Confidence Bound Technical Success 46 48 95 8 0 875 Procedure Success 46 46 100 0...

Страница 16: ...e or impingement on important surrounding cardiac structures Use echocardiographic measurements and an AMPLATZER Sizing Balloon II to determine the diameter of the defect Refer to the instructions for use included with the AMPLATZER Sizing Balloon II for more information Note If balloon sizing is performed in addition to echocardiographic measurements a stop flow technique should be used 6 Insert ...

Страница 17: ...the 2 components 19 Advance the delivery cable and device through the delivery sheath until the device reaches the tip of the delivery sheath Do not rotate the delivery cable CAUTION Do not advance the delivery cable and device if resistance is felt 20 Use angiography and echocardiography for guidance Hold the delivery cable in place while retracting the delivery sheath to deploy the left atrial d...

Страница 18: ...ion of the physician Go to www amplatzer com tempIDcard to print the temporary patient identification card Complete this card and give it to the patient If the patient would like to receive a permanent patient identification card complete the implant registration form and send the completed form to AGA Medical Disposal The carton and instructions for use are recyclable Dispose of all packaging mat...

Страница 19: ...at the buyer s expense returns the goods within the Warranty Period to SJM to the address below and after SJM confirms that the goods are defective SJM Amplatzer Products Product Surveillance Lab 14901 DeVeau Place Minnetonka MN 55345 2126 USA Tel 1 651 756 5833 To the maximum extent permitted by law if a mandatory term is implied by law or a mandatory consumer guarantee applies to the goods and t...

Страница 20: ...ed müüakse eraldi Laitteen ja sisäänviejäjärjestelmän mitat myydään erikseen Dimensions du dispositif et du système de pose vendus séparément Dimenzije umetka i uvodnog sustava prodaje se zasebno Az eszköz és a külön kapható bevezetőrendszer méretei Dimensioni del dispositivo e del sistema di introduzione venduti separatamente 기기 및 전달 시스템 치수 별매 Įtaiso ir įvedimo sistemos matmenys parduodama atskir...

Страница 21: ...63 80 9 ASD 028 28 42 38 4 9 DEL 10F 45 80 10 3 35 0 132 4 01 0 158 80 9 ASD 030 30 44 40 4 9 DEL 10F 45 100 10 3 35 0 132 4 01 0 158 100 9 ASD 032 32 46 42 4 9 ITV12F45 80 12 3 99 0 157 4 80 0 189 80 9 DEL 10F 45 80 10 3 35 0 132 4 01 0 158 80 9 DEL 10F 45 100 10 3 35 0 132 4 01 0 158 100 9 ASD 034 34 50 44 4 9 ITV12F45 80 12 3 99 0 157 4 80 0 189 80 9 DEL 12F 45 80 12 4 01 0 158 4 72 0 186 80 9 ...

Страница 22: ...l forgalomba Non disponibile in tutti i mercati 일부 국가에는 제공되지 않음 Prekiaujama ne visose rinkose Nav pieejams visos tirgos Niet in alle markten verkrijgbaar Ikke tilgjengelig i alle markeder Dostępne wyłącznie w wybranych krajach Não se encontra disponível em todos os mercados Nu este disponibil în unele ţări Доступно не во всех точках продажи Nie sú dostupné na všetkých trhoch Ni na voljo na vseh tr...

Страница 23: ...F1 D C F2 F G E H I J A B 100092311_ASD book Page 232 Monday January 6 2014 11 00 AM ...

Страница 24: ...dical para los que se han concedido patentes o cuyas patentes están pendientes en los EE UU y u otros países se encuentran enumerados en www amplatzer com patents Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and services marks of St Jude Medical Inc and its relat...

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