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

Model Number	IGK0008-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: INTERGARD KNITTED GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6420106
• Report Number: 1640201-2017-00005
• Device Sequence Number: 1102899
• Product Code: DSY
• UDI-Device Identifier: 00384401000938
• UDI-Public: 00384401000938
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other