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

Model Number IGKUT0008-40

Device Problem Hole In Material (1293)

Patient Problem Pseudoaneurysm (2605)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the complaint device history records (textile, greige prep and manufacturing record), indicated that the graft was processed and inspected according to established procedures.(b)(4).The involved device was returned to an external and independant laboratory for macroscopic observation.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

It was reported an "explantation of graft intergard ultrathin 8x40 implanted during a precedent surgery (in date (b)(6) 2012) for right popliteal artery replacement: during this second surgery, it was possible to see two big holes in the wall of the prosthesis.There was no sign of infection." additional information indicated that "the motivation of the 2nd surgery is the presence of a 5 cm pseudo-aneurysm of popliteal artery, caused by laceration of the prosthesis and confirmed by ct angiography.".

Manufacturer Narrative

(3331/213) a review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in textile records.Mechanical resistance tests performed on textile displayed results and values well within product specifications.(10/180) the involved device was returned to an external and independent laboratory for examination.The macroscopic analysis revealed presence of two large holes of 1x0,8cm and 3x1cm on the graft for which the margins, exhibiting signs of filament fraying, evoked graft tears.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) the outcome of our investigation would tend to indicate that the device was not defective at the time of manufacturing.Presence of two large holes was confirmed, probably as a result of mechanical force whose cause remains unknown.In addition, the corporate medical officer thoroughly reviewed the case, in collaboration with the involved surgeon.They agreed that the holes appear to be due to mechanical force but they were unable to come to any rationale for the findings.

• Brand Name: INTERGARD KNITTED ULTRATHIN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7568305
• MDR Text Key: 110028806
• Report Number: 1640201-2018-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401001270
• UDI-Public: 00384401001270
• Combination Product (y/n): N
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

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
• Device Operator: No Information
• Device Expiration Date: 05/01/2016
• Device Model Number: IGKUT0008-40
• Device Catalogue Number: IGKUT0008-40
• Device Lot Number: 11E05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 90