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

Model Number IGK1608

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso (b)(4).The test result indicated a value well within product specifications.The investigation is still on-going.A follow-up report will be sent upon completion of the investigation.

Event Description

During an abdominal aortic aneurysm surgery performed on (b)(6) 2016, it was reported a blood leak from the bifurcation of the main segment.Leg branch was cut and center area was used for straight pipe to continue the surgery.No adverse consequence for the patient was reported.

Manufacturer Narrative

(10/3287/213) one remaining fragment of the complaint device was sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned fragment and to evaluate the presence of collagen material.The sem analysis pointed out a massive collagen infiltration through the textile structure even though a post-sampling fungal and microbial contamination was noticed (related to the conditions of storage and transportation).No significant abnormality such as tears, loss of textile cohesion, holes or signs of cut were observed.The sem analysis corroborated the macroscopic analysis.(67) no conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: INTERGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6119998
• MDR Text Key: 60622304
• Report Number: 1640201-2016-00034
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: 00384401000488
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 16A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR