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

Model Number IGK0008-40

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

A review of the complaint 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 collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.Please note that water permeability testing is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.One retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value (0,01 ml/cm²/min) well within product specifications (< 5 ml/cm²/min).A remaining fragment of the involved device was returned for examination and it was sent to an external and independent laboratory.The objective of the study is to evaluate the presence of any structural abnormality visible on the external side of the remaining 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).Please note however that, as per the product instructions for use, the use of knitted vascular graft as a conduit for cannulation is not an approved indication.Indeed, intergard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.The investigation is still ongoing.A follow up report will be sent upon complementation of the investigation.

Event Description

It was reported that on (b)(6) 2017, during a mini invasive cardiac procedure, the graft was used for an extracorporeal circulation (ecc).The surgeon noticed bleeding from the graft, which was expected but according to his experience, it was too much.It was reported that the bleeding prolonged the duration of the procedure.The surgeon completed the procedure without replacing the graft.No harm to the patient was reported.

Manufacturer Narrative

(b)(4).

• 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 athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6420106
• MDR Text Key: 70408707
• Report Number: 1640201-2017-00005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000938
• UDI-Public: 00384401000938
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

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: 11/30/2020
• Device Model Number: IGK0008-40
• Device Catalogue Number: IGK0008-40
• Device Lot Number: 15M24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2015
• 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): Other