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

Model Number	HGK0008-70
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.No conclusion can be drawn.However, the outcome of the investigation would tend to indicate that the product was not defective at the time of manufacturing.
Event or Problem Description
During an iliofemoral bypass procedure performed on (b)(6) 2016, there was a lot of bleeding through the graft walls (more than "blush") when the clamp was removed.The surgeon had to manually coagulate the graft with the patient blood to control the bleeding, and worked the clamp open and closed to help to coagulate as well.The graft remained implanted and the patient was reported as being fine.
Additional Manufacturer Narrative
(b)(4).Two remaining fragments of the complaint device were sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned fragments and to evaluate the presence of collagen material.The sem analysis pointed out focal infiltration of collagen material.No significant abnormality such as large tear, loss of textile cohesion, holes and signs of cut were observed.The sem analysis corroborated the macroscopic analysis.(b)(4).No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: POLYESTER VASCULAR GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5979327
• Report Number: 1640201-2016-00028
• Device Sequence Number: 13595450
• Product Code: DSY
• UDI-Device Identifier: 00384401014157
• UDI-Public: 00384401014157
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2016

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: 01/31/2019
• Device Model Number: HGK0008-70
• Device Catalogue Number: HGK0008-70
• Device Lot Number: 14B13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement 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: Required Intervention