BEUDAMED
    FDA Adverse Event Death Summary report: N

    NITINOL U CLIP

    MDR report key: 329384 · Received April 26, 2001

    Report

    Report Number
    MW1021699
    Event Type
    Death
    Date Received
    April 26, 2001
    Date of Event
    April 19, 2001
    Report Date
    April 26, 2001
    Manufacturer
    UNK
    Product Code
    DSS
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A MINIMALLY INVASIVE CORONARY ARTERY BYPASS OF A SINGLE ARTERY. THE CLIPS WERE USED TO ANASTOMOSE THE BYPASS BLOOD VESSEL TO THE NATIVE BLOOD VESSEL. TWENTY MINS AFTER SURGERY, TWO OUT OF THE EIGHT CLIPS USED RUPTURED AND PT DIED 24 HRS LATER DUE TO HEMORRHAGE. NOT KNOWN IF FAULT IS OF THE CLIPS OR TECHNIQUE, OR PLACEMENT OF CLIPS. PT DIED FROM COMPLICATIONS OF RUPTURE OF THE VASCULAR ANASTOMOSIS WITH HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19292 NITINOL U CLIP SURGICAL CLIP DSS UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death