MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN GRAFT; VASCULAR POLYESTER GRAFT

Model Number	IGW0028-15
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the device history records indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests including a 100% visual inspection.No anomaly was found.(b)(4).An examination of the complaint device confirmed the presence of a collagen peel-off.Therefore, the product, as it was received, does not comply with its specification.(b)(4).The evaluation is still in progress.
Event or Problem Description
It was reported that, prior to a surgery performed at the beginning of (b)(6) 2016, the collagen coating was detached from the graft.The involved product was not used.No patient outcome has been reported.
Additional Manufacturer Narrative
(b)(4) upon investigation, the most probable root cause of the issue is that the collagen peel-off may have been generated during handling by the surgeon.This issue constitutes an isolated case and no corrective action is required.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.

• Brand Name: INTERGARD WOVEN GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5586410
• Report Number: 1640201-2016-00011
• Device Sequence Number: 10791820
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 00384401000235
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 14D24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2016
• Supplement Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1