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

Model Number	IGW0008-30
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
((b)(4)) a review of the 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.((b)(4)) one retention sample coated on the same period and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).((b)(4)) no conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective at the time of manufacturing.
Event or Problem Description
During an hemiarch replacement surgery, it was reported that oozing occurred on the body of the graft.The oozing issue did not require additional transfusion, nor prolonged surgery.It was reported that the patient was stable.
Additional Manufacturer Narrative
Following the receipt of the additional information, the case was reviewed by our corporate medical officer.His clinical opinion is the following: "the use of the intergard woven graft in an axillary position represents an off-label use.It is however a well published method of perfusion for this kind of procedure.The oozing is due, in most cases, to the high flow and shear stress through the graft.In this case, the oozing was self-contained and did not require an intervention or additional blood transfusion.The procedure was carried out without interruption or delay.The patient's post-operative course was uneventful." as per the instructions for use, intergard woven vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries.
Event or Problem Description
Additional information was obtained and confirmed that the graft was used for axillary cannulation.The graft was used until termination of the procedure.The oozing duration was approximately about 3-4 hours.

• Brand Name: INTERGARD WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7116891
• Report Number: 1640201-2017-00038
• Device Sequence Number: 16388265
• Product Code: DSY
• UDI-Device Identifier: 00384401000037
• UDI-Public: 00384401000037
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K970843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 03/31/2022
• Device Model Number: IGW0008-30
• Device Catalogue Number: IGW0008-30
• Device Lot Number: 17D27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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
• Patient Age: 53 YR