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

Model Number HGK0010-40

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/28/2017

Event Type  Injury  

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 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
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7141667
• MDR Text Key: 95590646
• Report Number: 1640201-2017-00040
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014218
• UDI-Public: 00384401014218
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: HGK0010-40
• Device Catalogue Number: HGK0010-40
• Device Lot Number: 13L28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR