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

Model Number	AG740
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint artegraft (collagen vascular graft) lot 17g195-007 was not returned to artegraft, inc.For evaluation as it was "repaired" by the surgeon during implant.The patient was reported to be in stable condition.A review of the production batch device history record was performed; no anomalies were identified.All grafts released from product batch 17g195 passed all of the requirements including wall thickness, pressure testing, sterility testing, and final visual inspection prior to final release to finished goods.The customer's allegation was not able to be confirmed as the graft remains implanted.No additional complaints from this product batch were reported to date.No confirmed complaint trend was identified related to thin graft wall and suture hole bleeding.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.
Event or Problem Description
Received a phone call from an approved distributor stating that during the implant of the artegraft (collagen vascular graft) a surgeon had "difficulty suturing".In follow-up communications it was clarified that the graft was "bleeding after every stitch" even using 7-0 size suture.The surgeon stated that the graft thickness was not the acceptable measurement; one end was ok, but the other end was "way too thin"."this caused major suture hole bleeding after every stich." the surgeon "oversewed and the bleeding was controlled".The implant was completed and the patient was stable.The surgeon has seen the patient in the office after the implant and the "graft is functioning fine".
Additional Manufacturer Narrative
Follow-up 001: a portion of the complaint graft (lot: 17g195-007) which was not implanted was returned to artegraft, inc.For evaluation.The calculated wall thickness on each end of the returned graft portion was verified to be within the required product specifications; therefore, the issue was not confirmed.(b)(4).

• 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: 7182202
• Report Number: 2247686-2018-00001
• Device Sequence Number: 143141
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(17)200731(10)17G195-007
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Device Lot Number: 17G195-007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/14/2018
• 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: 69 YR