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

Model Number AG740

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Return of the complaint graft has been requested by artegraft, inc.For evaluation.The complaint artegraft (collagen vascular graft) lot number 17m381-020 has not yet been returned for further evaluation.Several attempts have been made to obtain the graft.Should the graft be returned, or additional information become available, a follow-up report will be submitted.No adverse events to the patient were reported.A review of the device history record was performed; no abnormalities were identified.All grafts released from batch 17m381 passed the requirements for release, including: wall thickness, pressure testing, and final visual inspection prior to release to finished goods.No directly related non-conformnaces were identified to the leaking graft complaint.To date, no additional complaints from the batch have been reported.The complaint issue will continue to be monitored within artegraft, inc.Quality assurance trending.

Event Description

Artegraft, inc.Received an electronic implant usage card with a note stating "graft is defective and will be picked up by vendor for evaluation".Additional information was received from an approved distributor representative on behalf of a vascular surgeon (dr.(b)(6)) explaining that the graft had leaked during the pre-implant pressure test per the corresponding artegraft, inc.Ifu.The surgeon did not implant the graft (17m381-020).No patient adverse events were reported.

Manufacturer Narrative

(b)(4) mdr 2247686-2018-00007 follow up 001.Complaint graft 17m381-020 was received by artegraft, inc for evaluation.A note was written on the returned box stating "clip in area where leak was" a qualified manufacturing technician visually inspected the graft to artegraft, inc.Release specifications.A severe injured wall was identified near where the graft was visibly "clipped" by the physician, while a second injured wall was identified next to the area.An injured graft wall would have been detected during the artegraft, inc.Manufacturing final visual inspection step prior to release of any graft.The injured wall areas identified may have been caused by manipulation of the graft and "clipping" that was conducted by the physician.Additional functional testing was not performed as defects were visually identified on the returned graft as well as a clear manipulation (clipped) after being opened at the customer site.As this is a known issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant, which was conducted by the physician.Returned to manufacturer on 10/25/2018.Date received by mfr: 10/25/2018.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 7990809
• MDR Text Key: 126229248
• Report Number: 2247686-2018-00007
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000299
• UDI-Public: (01)00316837000299(17)210131(10)17M381-020
• Combination Product (y/n): N
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: AG740
• Device Catalogue Number: AG740
• Device Lot Number: 17M381-020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR