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

Model Number	AG636
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 5692931
• Report Number: 2247686-2016-00007
• Device Sequence Number: 13729
• Product Code: LXA
• UDI-Device Identifier: 00316837000237
• UDI-Public: (01)00316837000237(17)180531(10)15D103-017
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR