BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERGARD KNITTED VASCULAR PROSTHESIS

    MDR report key: 2823486 · Received November 2, 2012

    Report

    Report Number
    1640201-2012-00046
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 2012
    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

    NOTE: ALL INFO CONTAINED IN THIS REPORT IS PROVIDED BY THE MFR. FRAGMENTS OF THE COMPLAINT DEVICE WERE SENT TO AN OUTSIDE LABORATORY FOR SCANNING ELECTRON MICROSCOPY ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF SEVEN PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS SURGERY BETWEEN COMMON CAROTID AND SUBCLAVIAN ARTERIES, BLOOD LEAKING WAS OBSERVED FROM THE WHOLE GRAFT. THE BLEEDING WAS STOPPED AFTER ONE HOUR. THE GRAFT REMAINED IMPLANTED AND THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD KNITTED VASCULAR PROSTHESIS DSY INTERVASCULAR IGK0006-70 12A19

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other