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

Model Number IGK1608

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the complaint 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 7198.The test result indicated a value well within product specifications.Remaining fragments of the involved product have been sent to an outside laboratory for macroscopic and scanning electron microscopy analysis.The investigation is still on-going.A follow-up report will be submitted upon completion of the investigation.

Event Description

During an abdominal aortic aneurysm surgery performed on (b)(6) 2016, it was reported a blood leaking from the entire surface of the graft when declamped after the anastomosis of the left common iliac artery.The bleeding stopped by itself after half an hour.The graft remained implanted.No adverse consequence for the patient has been reported.

Manufacturer Narrative

(b)(4) remaining fragments of the involved device were analysed by an outside and independant laboratory.It consisted in a macroscopic examination and a scanning electron microscopy analysis.The laboratory concluded that no obvious anomaly was observed at macroscopy.The sem analysis pointed out presence of collagen material infiltration.No tears, filament rupture or signs of sectioning, loss of the textile cohesion, holes were observed.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 GRAFT
• 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: 5805076
• MDR Text Key: 49952937
• Report Number: 1640201-2016-00018
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2016
• Device Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 11H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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): Other