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

Model Number	AG745
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	Irritation (1941)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Artegraft, inc.Performed a review of the batch history record.Upon release, the batch met all requirements including pressure test results and graft wall thickness.Product evaluation was not able to be performed as the graft remains implanted and the patient is reported to be in stable condition.Photographs of the surgery prior to the suture of the graft "slit" were provided; however, no conclusions were able to be made based on the images.To date, no additional complaints were reported from the same product batch and no complaints for the same issue of implanted graft "blow out' were received in the past 2 years.It is unknown if procedural issues and/or patient interaction contributed to the reported event.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Graft remains implanted.
Event or Problem Description
An artegraft, inc.Approved distributor reported on behalf of the vascular surgeon that an artegraft (collagen vascular graft) which was implanted a "couple of weeks ago" "blew out"; a hole was noticed in the side of the graft.Upon follow-up communications, it was stated that the patient previously had blood flow issues and as a result, lost toes due to failed limb salvage.The artegraft was implanted in the patient's right femoral to popliteal during a limb salvage procedure on (b)(6) 2016.The reporter was unsure if the artegraft ifu required step for pre-implant pressure testing was performed by the surgical team.It was also stated that this was the hospitals first attempt at using an artegraft in a lower extremity.A few weeks after the surgery, the patient alleged noticeable irritation under the skin in the graft location.The surgeon initially attempted to place a vascular stent however, it failed in performance.Further exam identified a graft rupture.When the patient's leg was operated on (b)(6) 2016, coagulated blood was seen and about 3 cm from the anastomosis there was a ~1 cm "slit" in the graft.The surgeon was able to successfully suture the "slit" in the graft.The graft remains implanted and the patient is reported to be in stable condition.

• 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: 5750026
• Report Number: 2247686-2016-00008
• Device Sequence Number: 3427
• Product Code: LXA
• UDI-Device Identifier: 00316837000305
• UDI-Public: (01)00316837000305(17)180430(10)15D102-014
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2016

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: AG745
• Device Catalogue Number: AG745
• Device Lot Number: 15D102-014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/25/2016
• 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: 70 YR