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

Model Number	IGKUT0008-70
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Specifically, no anomaly was evidenced in the mechanical resistance tests records.The investigation is still on going.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
A cross femoro femoral bypass was performed on (b)(6) 2014 with the involved graft.Two years after implantation, it was reported on (b)(6) 2016 that the patient presents a false aneurysm in the path of the graft likely related to a breach of the graft frame.A scanner is scheduled for further surgery (removal of the graft).
Additional Manufacturer Narrative
The case has been submitted to our vice president, medical affairs.Pictures of the explanted graft as well as pictures of the patient before explantation were also provided.From his preliminary opinion, he noticed traces of blood onone edge of the explanted graft.Also he indicated that the fibrotic tissue covering the graft appeared to be incomplete.This is an indication that there was a possible leakage coming from the anastomotic site that through the years created a false aneurysm.According to him, this is a complication of vascular vessels repair/replacement.Additional information has been requested to the surgeon.In addition, the explanted device was sent to a external and independent laboratory for macroscopic analysis.A follow-up report will be sent to your attention upon completion of the investigation.
Event or Problem Description
The graft was explanted on (b)(6) 2016.
Additional Manufacturer Narrative
Additional information has been requested to the surgeon.However, in spite of repeated efforts, no information could be obtained.((b)(4)) the explanted device was sent to an external and independent laboratory for analysis.As no information was received from the surgeon, a full analysis has been requested to the external laboratory : - histopathological analysis in order to identify any signs of infection (if feasible, depending on the storage conditions) - enzymatic digestion of the tissues followed by macroscopic examination in order to identify: any tear, hole or break of the textile structure the integrity of the graft edges - sem examination of any abnormality found by macroscopic examination.It should be noted that additional delay was necessary due to some difficulties encountered for the enzymatic digestion of the tissues.Indeed, the laboratory decided to change the enzyme.The histopathologic analysis pointed out signs of infection and leakage (no endothelium, no extracellular matrix, signs of blood material from lumen to external side).Macroscopically, no signs of tear, hole or break of the textile structure were observed.The edges of the graft material (anastomotic junction) were not present.The conclusion of the external analysis was submitted to our corporate medical officer for his review.From his medical opinion, the analysis confirms the preliminary assessment made and is as follows : "it appears the false aneurysm was formed with time from a leakage.Despite the edges of the anastomosis are not contained in the sample, the analysis also confirms the integrity of the graft walls therefore it appears that the device was not the cause of the false lumen formation and it functioned as expected." ((b)(4)) the outcome of the investigation, which included the analysis performed on the explanted device, confirms the integrity of the graft walls.Therefore it appears that the device was not the cause of the false lumen formation.

• Brand Name: INTERGARD KNITTED ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6050132
• Report Number: 1640201-2016-00031
• Device Sequence Number: 75903
• Product Code: DSY
• UDI-Device Identifier: 00384401001171
• UDI-Public: 00384401001171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2016

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: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: IGKUT0008-70
• Device Catalogue Number: IGKUT0008-70
• Device Lot Number: 14D10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 12/23/2016; 06/16/2017
• 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: Other; Required Intervention