BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED GRAFT

    MDR report key: 7048347 · Received November 21, 2017

    Report

    Report Number
    1640201-2017-00037
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 21, 2017
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401014225
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830097 HEMAGARD KNITTED GRAFT VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS HGK0010-70 17F15 00384401014225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention