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

Model Number AG636

Device Problem Break (1069)

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

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Artegraft, inc.Performed a review of the batch history records; upon release, the batch met all requirements including pressure test results.To date, no additional complaints were reported from the same product batch and no complaints for the same issue of "broken graft during tunneling" were received in the past 2 years.It is unknown if procedural issues contributed to the reported event.Upon completion of evaluation of the returned product, a follow-up report will be submitted.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.

Event Description

An approved distributor reported on behalf of the vascular surgeon that during the tunneling procedure of graft implantation, the artegraft (collagen vascular graft) "broke".The surgery was able to be completed using a second artegraft device.Details of the procedure were requested by artegraft; however, to date were not provided.

Manufacturer Narrative

Evaluation of the returned vascular graft (15d103-017) was performed.The vascular graft was returned to artegraft, inc.Not in its original packaging and without liquid storage solution, which may have affected the consistency of the graft.Possible root causes for the graft being torn may be due to excessive external forces, such as the type of tunneling device, size of needle, and amount of pressure applied.Per the artegraft website faq (http://artegraft.Com/products/faqs), it is not recommended that artegraft be inserted and pulled through the lumen of a tunneling device.Information on type of tunneler, technique, and needle size were requested from the customer but was not provided to artegraft.To date, no additional complaints were reported for this issue of "broken graft during tunneling" and no complaints were reported from the same product batch.

• 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: 5692931
• MDR Text Key: 46368178
• Report Number: 2247686-2016-00007
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000237
• UDI-Public: (01)00316837000237(17)180531(10)15D103-017
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: AG636
• Device Catalogue Number: AG636
• Device Lot Number: 15D103-017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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: 63 YR