BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

    MDR report key: 868304 · Received June 20, 2007

    Report

    Report Number
    6000089-2007-00848
    Event Type
    Death
    Date Received
    June 20, 2007
    Date of Event
    May 21, 2007
    Report Date
    May 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PMA/510: P860019/S179.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER'S REPORT # 6000089-2007-00847. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT DIED. THE 100% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LIBERTE MONORAIL STENT WAS REPORTEDLY BEING USED TO REPAIR A DISSECTION CAUSED BY ANOTHER MANUFACTURER'S STENT IN THE PROXIMAL ALD. AFTER SUCCESSFULLY DEPLOYING THE LIBERTE STENT INSIDE THE OTHER MANUFACTURER'S STENT, IT WAS NOTED THAT THE LIBERTE MONORAIL STENT STRUT OBSTRUCTED THE FLOW OF BLOOD TO THE LEFT CIRCUMFLEX (CX) CORONARY ARTERY. SUBSEQUENTLY, THE PHYSICIAN USED A MAVERICK2 MONORAIL CATHETER TO CROSS THE CX. UPON DIFFICULTY REMOVING THE LIBERTE MONORAIL STENT DELIVERY SYSTEM (SDS) FROM THE LAD, THE PHYSICIAN ATTEMPTED TO WITHDRAW BOTH THE MAVERICK2 MONORAIL CATHETER AND THE LIBERTE SDS. CONSEQUENTLY, THE PROXIMAL SHAFT OF THE MAVERICK2 MONORAIL CATHETER SEPARATED. THE SEPARATED PORTION OF THE CATHETER WAS WITHDRAWN BY A SNARE CATHETER. FOLLOWING THESE EVENTS, THE PATIENT DIED. THE TIMEFRAME BETWEEN THE EVENT AND DEATH IS UNKNOWN. THE CAUSE OF DEATH AND DATE UNKNOWN. THE DEATH CERTIFICATE AND AUTOPSY RESULT ARE NOT AVAILABLE. ACCORDING TO THE PHYSICIAN, "THE DEVICE AND DEATH OF THE PATIENT DID NOT HAVE CAUSATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS MAF STENT CORONARY MAF BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death RINATO GUIDEWIRE| ZUMA2 6F JL4 GUIDE CATHETER| MAVERICK2 15/3.0 BALLOON CATHETER| BMW GUIDEWIRE| DRIVER 3.0 X 24 MM STENT