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

Model Number	HGK0010-70
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption e2017024 : intervascular sas (manufacturer) is submitting the report on behalf of maquet cardiovascular, llc (importer).(10/3317/213) 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.(3340/3345/213) one retention sample coated on the same period 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).(24) please note however that, as per the product instructions for use, the use of a knitted vascular graft as a conduit for cannulation is not an approved indication.Indeed, hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.(67) no conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective at the time of manufacturing.
Event or Problem Description
During a bedside ecmo cannulation procedure performed on (b)(6) 2017 in the cardiac icu intervention, blood leaking occurred while hemagard 10 mm knitted graft was used as a cannula.The graft was used as a conduit as an accessory to pass the blood.The blood leaking was stopped by adding factors such as ffp and a packing and wrapping of the graft.Blood transfusion was required and the intervention was longer than expected.The graft was not available for investigation as it was tossed out after the procedure because it was used externally as a conduit.It was reported that the patient was very sick and had a severe cardiomyopathy.It was also reported that the patient died on (b)(6) 2017 due to other causes, not related to the hemagard graft event.

• Brand Name: HEMAGARD KNITTED GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7048347
• Report Number: 1640201-2017-00037
• Device Sequence Number: 13926968
• Product Code: DSY
• UDI-Device Identifier: 00384401014225
• UDI-Public: 00384401014225
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: 05/31/2022
• Device Model Number: HGK0010-70
• Device Catalogue Number: HGK0010-70
• Device Lot Number: 17F15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2017
• Device Age: 17 WK
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/21/2017
• 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