2
ADVERSE EVENTS
The Angio-Seal Device was evaluated in a non-randomized clinical trial involving 306 patients in whom the access sites were closed with the device following diagnostic angiography
(n=97) or percutaneous coronary intervention (n=209) procedures. Table 1 reports the adverse events as a percentage of patients who received the Angio-Seal Device in the clinical
investigation.
Table 1: Percentage of Patients Experiencing Adverse Events
Adverse Event
8F/6F
Diagnostic
(n=97)
8F
Interventional
(n=106)
6F
Interventional
(n=103)
Minor Complication
Hematoma >6 cm
0%
4 (3.8%)
1 (1.0%)*
Infection w/o hospitalization
0%
0%
0%
False aneurysm w/o intervention
0%
0%
0%
AV Fistula
0%
1 (0.9%)
0%
Deep Vein Thrombosis
0%
0%
0%
Vasovagal Response
0%
1 (0.9%)
0%
Device Non-Deployment
0%
0%
3 (2.9%)
Device Malfunction
0%
0%
0%
Major Complication
Vascular Repair
0%
0%
1 (1.0%)
Late GI bleeding requiring transfusion
0%
0%
1 (1.0%)** †
Infection w/ hospitalization
0%
0%
0%
False aneurysm requiring intervention
0%
0%
1 (1.0%)**
DVT requiring intervention
0%
0%
0%
AV Fistula requiring intervention
0%
0%
0%
Retroperitoneal bleeding requiring
intervention
0%
1 (0.9%)
0%
Any Complication ‡
0%
7 (6.6%)
4 (3.9%) ‡
Major Complication
0%
1 (0.9%)
3 (2.9%)
* One patient had hematoma > 6cm combined with DVT.
** Not device related.
† Patient also experienced a hematoma < 6cm.
‡ Not including device non-deployments
No deaths occurred during the study.
Based on clinical experience, the following describes possible treatments for risks or situations that are associated with use of the Angio-Seal Device or vascular access procedures.
•
Bleeding or hematoma
– Apply light digital or manual pressure to the puncture site. If manual pressure is necessary, monitor pedal pulses.
•
AV fistula or pseudoaneurysm
– If suspected, the condition may be evaluated with duplex ultrasound. When indicated, ultrasound guided compression of a pseudoaneurysm may be
used after the Angio-Seal Device has been placed.
•
Device non-deployment
– If device pulls out with sheath upon withdrawal, apply manual or mechanical pressure per standard procedure. Examine the device to ensure all
absorbable components have been withdrawn.
•
Anchor fracture or embolism
– Examine device to determine if anchor has been withdrawn. If bleeding occurs, apply manual or mechanical pressure to the puncture site per
standard procedures. If anchor is not attached to the device, monitor the patient (for at least 24 hours) for signs of vascular occlusion. Clinical experience to date indicates that tissue
ischemia from an embolized anchor is unlikely. Should ischemic symptoms appear, treatment options include thrombolysis, percutaneous extraction of the anchor or fragments, or
surgical intervention.
•
Infection
– Any sign of infection at the puncture site should be taken seriously and the patient monitored carefully. Surgical removal of the device should be considered whenever an
access site infection is suspected.
•
Collagen deposition into the artery or thrombosis at puncture site
– If this condition is suspected, the diagnosis can be confirmed by duplex ultrasound. Treatment of this event may
include thrombolysis, percutaneous thrombectomy, or surgical intervention.
•
Very thin patients
– Collagen may protrude from the skin after compaction has been completed. Attempt to push the collagen under the skin using the compaction tube or a sterile
hemostat. DO NOT apply vigorous compaction as this may result in anchor fracture. DO NOT cut off the excess collagen, as the suture woven through the collagen may be cut and
the integrity of the anchor/collagen sandwich could be compromised.
The following potential adverse reactions or conditions may also be associated with one or more Angio-Seal Device components (i.e., collagen, synthetic absorbable suture, and/or
synthetic absorbable polymer):
• Allergic
reaction
• Foreign body reaction
• Potentiation of infection
• Inflammation
• Edema
CLINICAL TRIALS
Safety and Effectiveness Study
The Angio-Seal Vascular Closure Device with a self-tightening suture was evaluated in a multicenter non-randomized study designed to examine the safety and effectiveness of femoral
artery closure using the 8F and 6F Angio-Seal Device following arterial cannulation during diagnostic angiography and percutaneous coronary intervention procedures.
The study was conducted in the United States at nine institutions involving 306 patients. Patients eligible for participation included candidates for early ambulation and patients who were
clinically indicated for a diagnostic or an interventional cardiac procedure involving access through the femoral artery using an 8F sheath or smaller for the 8F Angio-Seal or a 6F sheath
or smaller for the 6F Angio-Seal. Exclusion criteria included patients with known allergies to the materials used in the device, severe acute non-cardiac systemic disease, evidence of
systemic infection, coagulopathy, thrombolytic medication use reducing
fi
brinogen to less than 100 mg/dl, use of intra-aortic balloon pump support (ipsilateral), sheath in place for more
than 36 hours, suspected double wall puncture, pre-existing hematoma, pregnancy/lactation, or indication that the puncture had been made in the profunda femoris or at the bifurcation of
the common femoral artery.
Patients’ ages ranged between 30.3-85.8 (mean 62.7 ± 11.7). Most (71.6%) of the patients were male. The 6F Angio-Seal was used in 85 (88%) diagnostic patients and 103 (49%)
interventional patients. A total of 144 (68.9%) interventional patients were being treated with GP IIb/IIIa inhibitors. The mean activated clotting time for interventional patients was 299.6 ±
85.0 seconds.
