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

Model Number	HGK0008-20
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not accessible for testing as it remained implanted in patient.A review of the complaint device history records indicated that the graft was processed and inspected according to established 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.One retention sample coated on the same day and under the same conditions as the complaint device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).The review of post-marketing historical data indicated that no other similar complaint was reported for the same product family and same lot number.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.Please note that, as per the product instructions for use, the use of knitted vascular grafts as a conduit for cannulation is not an approved indication.Indeed, hemagard 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.
Event or Problem Description
The concerned graft was used as an extracorporeal vessel channel.The graft leaked during surgery.Patient endangered but not injured.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8093977
• Report Number: 1640201-2018-00023
• Device Sequence Number: 11259465
• Product Code: DSY
• UDI-Device Identifier: 00384401014133
• UDI-Public: 00384401014133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 12/31/2021
• Device Model Number: HGK0008-20
• Device Catalogue Number: HGK0008-20
• Device Lot Number: 17A05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60