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

Model Number	M002020951080
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review performed by our quality assurance supervisor 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).A retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The testing was supervised by our quality assurance supervisor.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(b)(4).No conclusion can be drawn.However, all available information and testing performed would tend to indicate that the product was not defective.(b)(4).Please note 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, hemashield gold knitted graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Event or Problem Description
During a cardiac surgery performed on (b)(6) 2017, the involved graft was used to cannulate the axillary artery for cardiopulmonary bypass.The graft was soaked with rifampicin before the case for about 10 minutes.It was reported that excessive weeping/bleeding through the graft was noticed during the procedure.

• Brand Name: HEMASHIELD GOLD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6303630
• Report Number: 1640201-2017-00003
• Device Sequence Number: 34249
• Product Code: MAL
• UDI-Device Identifier: 00384401017363
• UDI-Public: 00384401017363
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2017

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: 02/28/2021
• Device Model Number: M002020951080
• Device Catalogue Number: M002020951080
• Device Lot Number: 16C16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/06/2017
• 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