MAUDE Adverse Event Report: ARTEGRAFT, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number	AG750
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Codes	Thrombus (2101); Pseudoaneurysm (2605)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject artegraft (collagen vascular graft) was not returned to artegraft, inc.For evaluation.A review of the production batch record was performed; no anomalies were identified.All grafts released from product batch 16k249 passed all of the requirements including pressure testing prior to final release to finished goods.Artegraft, inc.Scientific advisor (qualification: m.D., f.A.C.S.) reviewed the case details and stated that "the extensive nature of the vascular disease was consistent with the patients underlying co- morbidities.The fact that these patients were not immediately amputated is a testament to the skill of the surgeon.I reviewed his operative reports and he did everything humanly possible to preserve the patients lower extremities.I see no indication that there was any deviation from standard protocol in the graft manufacturing process to account for the pseudoaneurysms." the patient had "multiple procedures in very difficult circumstances, so it is impossible to know the etiology of the pseudoaneurysm." aneurysm is a known issue; artegraft, inc.Ifu adverse reaction section states that "true aneurysms have been reported.In view of this, patients with implanted artegrafts should be observed so that appropriate action can be taken if an aneurysm should occur.This adverse reaction should also be considered when treating conditions in which extended periods of implantation are expected".No confirmed complaint trend was identified related to pseudoanurysm.All product quality and clinical issues will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.
Event or Problem Description
A vascular surgeon notified artegraft, inc.Vp of sales during a medical conference that he had 2 patients having a description of "the ligature broke off of the side branches which resulted in aneurysm formation in the graft".Follow-up information was provided.This report is specific for patient 1 of 2 (a separate report mdr 2247686-2017-0006 will be submitted for patient 2).On (b)(6) 2017 the patient had a thrombectomy and patch angioplasty of the left popliteal artery.Viabahn (w.L.Gore) stents were placed in the left popliteal artery.Left popliteal artery tpa infusion on (b)(6) 2017 the vascular surgeon implanted an artegraft (collagen vascular graft) lot 16k249-043 in the patient's left distal superficial femoral artery to posterior tibial artery.On (b)(6) 2017, left lower extremity graft thrombectomy.6 cm pseudoaneurysm of the left sfa to below knee popliteal bypass autograft with no pus.Intraoperative gram stain negative.The surgeon removed the aneurysmal section of the artegraft (lot 16k249-043) and bypass was completed using rifampin-soaked 7 mm ringed ptfe graft, placed interposition from the proximal and distal end of the autograft in end-to-end fashion.The patient tolerated the procedure well.On (b)(6) 2017, exploration of the left femoral popliteal graft, excision of infected distal sfa to the posterior tibial artery graft to include autograft and an interposition ptfe graft, excision of infected left distal popliteal artery patch, hemostasis of pseudoaneurysm, for the left popliteal artery, debridement of the patient's left leg.The patient reportedly has an extensive medical history.The subject graft was not returned to artegraft, inc.For evaluation.

• Brand Name: ARTEGRAFT
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 6681454
• Report Number: 2247686-2017-00005
• Device Sequence Number: 1539276
• Product Code: LXA
• UDI-Device Identifier: 00316837000312
• UDI-Public: (01)00316837000312(17)191031(10)16K249-043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: AG750
• Device Catalogue Number: AG750
• Device Lot Number: 16K249-043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91