MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED GRAFT; VASCULAR POLYSESTER 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	07/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device evaluation was performed since the device was not returned to the manufacturer and the product identifier was not provided.No review of the device history record was done since the product identifier has not been provided at the date of this report.No conclusion can be drawn.Please note that, as per instruction for use, the device was not used in an approved indication.
Event or Problem Description
During a redo aortic valve replacement (avr) procedure performed on (b)(6) 2016, the graft was used as a conduit for axillary artery cannulation.When the clamp was removed, there was a lot of oozing from the graft and the graft had to be wrapped with a hemostatic agent.The case was completed.No adverse outcome for the patient was reported.No additional information on the product serial number could be obtained at the date of this report.
Additional Manufacturer Narrative
A review of the 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, all available information and the product testing performed would tend to indicate that the device was not defective.
Event or Problem Description
Additional information confirmed that the product did not remain implanted and was removed at the end of the procedure.

• Brand Name: HEMAGARD KNITTED GRAFT
• Common Device Name: VASCULAR POLYSESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5846118
• Report Number: 1640201-2016-00021
• Device Sequence Number: 18944194
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: 05/31/2020
• Device Model Number: HGK0008-70
• Device Catalogue Number: HGK0008-70
• Device Lot Number: 15F18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 08/16/2016
• 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