BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERGARD KNITTED GRAFT

    MDR report key: 3240801 · Received July 16, 2013

    Report

    Report Number
    1640201-2013-00018
    Event Type
    Other
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FRAGMENTS OF THE COMPLAINT DEVICE WERE SENT TO AN OUTSIDE LAB FOR SCANNING ELECTRON MICROSCOPY ANALYSIS. A REVIEW OF THE DEVICE HISTORY REVIEW, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF EIGHT 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. THE INVESTIGATION IS STILL ON GOING. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A VASCULAR SURGERY PERFORMED ON (B)(6) 2013, BLEEDING OCCURRED FROM THE GRAFT WALL. THE AMOUNT OF BLEEDING WAS ABOUT 50ML. THE OPERATION WAS PROLONGED IN ORDER TO STOP THE BLEEDING. THE GRAFT REMAINED IMPLANTED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330228 INTERGARD KNITTED GRAFT DSY INTERVASCULAR IGKAX0808RS45/30 10A21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other