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

Model Number	AG745
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint artegraft (collagen vascular graft) lot 15k263-027 was returned to artegraft, inc.For evaluation.The graft inner/outer diameters and length were verified as compared to the dhr release data.The thickness of the graft wall was calculated as 0.5 mm; this is well within the required acceptable range (0.25mm - 1.5mm) for the product.The customer's allegation of leaking graft pre-implant was confirmed; during the investigative pressure testing (per artegraft, inc.Process specification) bubbles were seen coming from a tributary of the graft.Additionally, 4 indents in the graft wall were observed.Possible root causes for the leaking graft may be that a ligation suture on the graft tributary loosened.The 4 indents observed in the graft wall indicate that the graft may have been mishandled during the pre-implant testing; possibly from the clamp that was applied by the surgeon during the pre-implant testing.It is also possible that too much force was applied during the pre-implant pressure test.No additional information is available regarding the tools/methods utilized by the customer for pressure testing for this incident.As this is a known issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.Capa was previously initiated to investigate similar occurrences involving graft wall leaks pre-implant.Additional quarterly analysis of the grafts was implemented for post-sterilization data and trending.This graft was manufactured in 2015, prior to capa closure.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 or Problem 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.In follow-up conversations with the rn from the hospital it was explained that the issue was identified during the graft flushing process; one end of the graft was clamped and saline solution was being flushed into the lumen of the graft.While marking the graft with a directional line, the surgeon noticed the graft was leaking mid-length near a side branch.The surgeon did not implant the graft (15k263-027).Another artegraft ag745 was used to complete the surgery without issue.No patient adverse events were reported.The complaint graft was returned to the original sterilization solution in the artegraft product culture tube (without the plastic support rod) and was returned to artegraft inc.

• 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: 6411261
• Report Number: 2247686-2017-00002
• Device Sequence Number: 16262049
• Product Code: LXA
• UDI-Device Identifier: 00316837000305
• UDI-Public: (01)00316837000305(17)181031(10)15K263-027
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/17/2017

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: 10/31/2018
• Device Model Number: AG745
• Device Catalogue Number: AG745
• Device Lot Number: 15K263-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1