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

Model Number AG730

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint artegraft (collagen vascular graft) lot 17a008-009 was not returned to artegraft, inc.For evaluation as it was repaired and implanted.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 17a008 passed all of the requirements including pressure testing prior to final release to finished goods.The customer's allegation of leaking graft pre-implant was not able to be confirmed as the graft remains implanted.As this is a known issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.This step was correctly completed by the implanting surgeon.To date, no additional complaints were reported from this product batch.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 Description

Artegraft inc.Received an email communication from an authorized distributor that an artegraft (collagen vascular graft) was identified as leaking during the pre-implant pressure testing per the corresponding artegraft ifu.The surgeon noted that the graft appeared to have a small 1 mm hole in it and was leaking in the middle of the graft, not near a branch.The surgeon was able to repair the graft hole with 6.0 prolene suture and the graft (lot: 17a008-009) was successfully implanted.No patient adverse events were reported.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 6955649
• MDR Text Key: 90441058
• Report Number: 2247686-2017-00009
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000275
• UDI-Public: (01)00316837000275(17)200131(10)17A008-009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: AG730
• Device Catalogue Number: AG730
• Device Lot Number: 17A008-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR