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

Model Number	HGK0010-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.One retention sample coated on the same day 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).No conclusion can be drawn.However, the investigation performed would tend to indicate that the device was not defective at the time of manufacturing.
Event or Problem Description
It was reported that following an internal illiac artery surgery performed on (b)(6) 2017 at 12:30 pm, the blood pressure became unstable.A lot of bleeding was confirmed by computerized tomography (ct) scan.As a consequence, a second operation started at 18:00 pm, the bleeding was observed from several points of the graft surface.The bleeding was stopped by clamping and applying hemostatic agents (tacocom® and tisseel®).The graft remained implanted in the patient.Approximatively, 1.5l blood was lost, which required blood transfusion.The patient's condition was stable at the date of the report by the hospital.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7141667
• Report Number: 1640201-2017-00040
• Device Sequence Number: 1132486
• Product Code: DSY
• UDI-Device Identifier: 00384401014218
• UDI-Public: 00384401014218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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 Model Number: HGK0010-40
• Device Catalogue Number: HGK0010-40
• Device Lot Number: 13L28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/22/2017
• 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
• Patient Age: 81 YR