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

Model Number IGK0010-40

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The (10/3317/213) 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.The (3340/3345/213) 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.The investigation is still on-going.A follow-up report will be sent upon completion of the investigation.

Event Description

During a cardiac surgery, it was reported a diffuse and strong bleeding from the graft wall, through all length, after implantation.The bleeding could not be stopped.The graft was explanted and another one was implanted.No additional information could be obtained at the date of this report.

Manufacturer Narrative

A piece of the graft was returned for examination.It was sent to an external and independent laboratory, it should be noted that this fragment was stored in a surgical glove from the date of the surgery until it was sent to the laboratory for examination.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 analysis consisted of a macroscopic observation of the fragment and a scanning electron microscopy (sem).The sem analysis pointed out a massive and heterogeneous collagen material infiltration through the textile structure.The heterogeneous pattern of the collagen (disrupted collagen material) was likely related to the poor storage conditions of the prosthesis before receipt at the laboratory for analysis.No significant abnormality such as tears, loss of textile cohesion, holes and signs of cut were observed.The sem analysis corroborated the macroscopic analysis.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: 6056807
• MDR Text Key: 58406902
• Report Number: 1640201-2016-00032
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000389
• UDI-Public: 00384401000389
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2018
• Device Model Number: IGK0010-40
• Device Catalogue Number: IGK0010-40
• Device Lot Number: 13G18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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