Boston Scientific AMS 800 Instructions For Use Manual Download Page 2

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English

Catalog Number

Do Not Reuse

Do Not Resterilize

Consult Instructions for Use

Upper Limit of Temperature

Sterilized Using Ethylene Oxide

Sterilized Using Steam

Lot Number

Date of Manufacture

Use by YYYY-MM-DD

Manufacturer

Authorized Representative in the European Community

Recyclable Packaging

Non-sterile

CAUTION: Federal law (U.S.) restricts this device to sale by or on the order

of a physician.

Summary of Contents for AMS 800

Page 1: ...AMS 800 Urinary Control System For Male Patients Instructions For Use AMS 800 Urinary Control System For Male Patients Instructions For Use 1 English ...

Page 2: ...ture IQ en Sterilized Using Ethylene Oxide IS en Sterilized Using Steam g en Lot Number N en Date of Manufacture H en Use byYYYY MM DD en Manufacturer en Authorized Representative in the European Community en Recyclable Packaging en Non sterile en CAUTION Federal law U S restricts this device to sale by or on the order of a physician ...

Page 3: ...e amounts of rifampin and minocycline contained on a prosthesis implant are represented by the means and 95 tolerance intervals of the following implant configurations 1 9 mg rifampin 0 7 3 1 mg and 2 8 mg minocycline 2 1 3 5 mg for the implant configuration with the lowest drug levels i e single 4 0 cm cuff control pump 3 7 mg rifampin 0 9 6 5 mg and 6 3 mg minocycline 4 7 8 0 mg for the implant ...

Page 4: ...tients with urge incontinence overflow incontinence detrusor hyperreflexia or bladder instability should have these conditions treated and controlled or resolved prior to implantation of the device 5 Do not pass a catheter or any other instrument through the urethra without first deflating the cuff and deactivating the device to prevent potential damage to the urethra or the AMS 800 6 This device ...

Page 5: ...erity and duration 4 Tissue fibrosis previous surgery or previous radiation therapy in the area of the implant may preclude implantation of a cuff at the bulbous urethra or bladder neck 5 Any progressively degenerative disease e g multiple sclerosis may limit the future usefulness of the implanted prosthesis as a treatment for the patient s urinary incontinence 6 Adequate manual dexterity strength...

Page 6: ...d to for the use of this device although systemic levels of minocycline and rifampin rifampicin in patients receiving this device are unlikely to be detected Surgery Related 1 Improper cuff sizing improper balloon selection or other causes may result in tissue erosion migration of components or continued incontinence 2 Component migration can occur if the cuff is sized improperly if the pump or ba...

Page 7: ... 0 1 0 Swelling 2 2 2 0 2 1 Hydrocele 1 1 1 0 1 1 Tissue Erosion Infection 1 1 1 0 0 1 Patient Dissatisfaction 1 1 1 0 0 1 Positional Incontinence 1 1 0 1 0 0 Wound Infection 1 1 1 0 1 0 Urinary Retention 1 1 1 0 1 0 Events may have been addressed with more than one type of intervention Medical interventions included medication education frequent device deactivation dressing changes and catheteriz...

Page 8: ...nce specific quality of life questionnaire The primary safety endpoint evaluated the five year revision free rate using a Bayesian hierarchical model The safety endpoint was a five year revision free rate equivalent to 75 using a 10 delta with a two sided 95 lower bound greater than 65 Incontinence Impact Scores The primary effectiveness endpoint was a reduction in Incontinence Impact Score from p...

Page 9: ... mechanical malfunction Two 2 revisions were due to recurrent incontinence Two 2 revisions were due to erosion Two 2 revisions were due to infection One 1 revision each total 6 was due to migration pain erosion infection persistent incontinence patient dissatisfaction recurring incontinence malfunction infection pain urethrocutaneous fistula Multiple reasons were provided for some revisions Four o...

Page 10: ...multiple reasons were sometimes provided for a single revision Therefore in order to stratify this revision data by reason all occurrences were included and presented as reason The total number of reasons therefore exceeds the total number of revisions reported for these studies Table 3 Reasons for Revision in Three Different Studies Prospective Study PIF Study Retrospective Study Revision Reasona...

Page 11: ...free rate for the AMS 800 is approximately 73 8 with 95 CI ranging from 67 3 to 79 6 The results met the primary safety endpoint for the clinical study of a five year revision free rate at 75 using a 10 delta with two sided 95 lower bound greater than 65 Estimated Survival Rates Revision Free Rate Time in Months Prospective Survival Rate _____ Bayesian Survival Rate Figure 1 Estimated Survival Rat...

Page 12: ...ent time is defined as the time between the implantation of the original device in the study period and the first replacement revision or removal of any component of the device due to infection mechanical malfunction patient problem or other reason If there was no event the patient was censored at end of the study period For the Revision Surgery Group device event time is defined for the time betw...

Page 13: ...sed on the voluntary submission of AMS implant registration data using the AMS PIF While there was a relatively high PIF return rate there was not 100 compliance Study Visits and Length of Follow up As the study utilizes a voluntary implant registration data form to report events i e PIF for Original Surgery Group and the Revision Surgery Group there were no specified study visit intervals Overall...

Page 14: ...AMS 800 PIF reports included in the survival analyses were from a total of 17 063 original implant surgeries including 13 060 76 5 IZ devices and 3 742 21 9 Non IZ devices The remaining 261 1 5 implants a mix of IZ and Non IZ components were removed from additional statistical analysis Revision free patients totaled 14 410 85 8 Only 2 392 revisions 14 2 were recorded of which 1 621 12 4 revisions ...

Page 15: ... free rate The IZ group demonstrated a 27 6 relative risk reduction of infection malfunction compared to the Non IZ group Revisions Due to MECHANICAL MALFUNCTION Malfunction free patients totaled 5 945 95 2 A total of 298 events 4 8 were recorded as events due to mechanical malfunction with the IZ group reporting 183 4 2 events i e 95 8 malfunction free rate and 115 6 1 events in the Non IZ group ...

Page 16: ...ain comparable Final Safety Findings key endpoints The study demonstrated the IZ antimicrobial impregnation did not affect the mechanical performance of the device The study demonstrated the IZ antimicrobial impregnation devices in both original and revision surgery groups consistently had slightly higher revision free rates overall for infection and mechanical malfunction In addition the correspo...

Page 17: ... 17 5 5 0 25 Escherichia coli 6 5 2 6 24 Enterococcus faecalis 4 8 6 7 21 Candida albicans 0 1 0 4 21 Proteus mirabilis 0 6 1 0 17 obtained using standardized KRT test samples containing approximately 12µg minocycline and 26 µg rifampin rifampicin the isolates tested were not susceptible to rifampin rifampicin and or minocycline control disks An animal infection study was conducted using 11 rabbit...

Page 18: ...nown clinical sequelae to this phenomenon Magnetic Resonance Imaging MRI Important Safety Information Non clinical testing has demonstrated the AMS 800 product line is MR Conditional The device can be scanned safely under the following conditions Static Magnetic Field 1 5 Teslaa 3 0 Teslab Spatial Gradient Field 450 Gauss cm or less 720 Gauss cm or less Maximum whole body averaged Specific Absorpt...

Page 19: ...to returning any product This document is written for professional medical audiences Contact American Medical Systems for lay publications American Medical Systems periodically updates product literature If you have questions about the currency of this information contact American Medical Systems References 01 Shumaker SA Wyman JF Ubersax JS McClish JA Fantl JA Health related Quality of Life Measu...

Page 20: ...netonka MN 55343 U S A U S Toll Free 800 328 3881 Tel 1 952 930 6000 Tel 31 20 593 8800 2017 Boston Scientific Corporation or its affiliates All Rights reserved All trademarks are the property of the respective owners 1004680 P N 1004681 A W Rev A 2017 02 ...

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