BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 934715 · Received October 29, 2007

    Report

    Report Number
    6000093-2007-02047
    Event Type
    Death
    Date Received
    October 29, 2007
    Date of Event
    September 28, 2007
    Report Date
    October 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 6000093-2007-02046. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED AND PT COMPLICATIONS OCCURRED, WITH PT DEATH OCCURRING FIVE DAYS LATER. THE LESION BEING TREATED WAS LOCATED IN THE 90% STENOTIC, MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 20MM IN LENGTH, WITH A VESSEL DIAMETER OF 3 TO 4MM, WITH TIMI 3 FLOW PRESENT. ANOTHER LESION WAS LOCATED IN THE 2ND DIAGONAL, 10MM IN LENGTH WITH A VESSEL DIAMETER OF 2.5MM WITH TIMI 3 FLOW PRESENT. THE PHYSICIAN PREDILATED THE LAD WITH A 2.25X15MM QUANTUM MAVERICK BALLOON AT 8 ATMS, THEN PREDILATED THE 2ND DIAGONAL WITH A 1.50X9MM NON-BSC BALLOON FOR 30 SECS AND THEN 25 SECS AT 12 ATMS. ST SEGMENT ELEVATION WAS OBSERVED AT THIS TIME. THE MID LAD WAS PREDILATED AGAIN FOR 20 SECS AT 16 ATMS. A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED IN THE 2ND DIAGONAL FOR 30 SECONDS AT 10 ATMS. THE TAXUS STENT WAS THEN POST-DILATED WITH THE QUANTUM MAVERICK BALLOON FOR 15 SECS AT 14 ATMS. NEXT, THE PHYSICIAN IMPLANTED A 2.50X23MM NON-BSC DRUG ELUTING STENT IN THE LAD AT 16 ATMS FOR 30 SECS. THE NON-BSC STENT OVERLAPPED THE TAXUS STENT. THE NON-BSC STENT WAS POST-DILATED WITH THE QUANTUM MAVERICK BALLOON FOR 20 SECS AT 14 ATMS, 25 SECS AT 12 ATMS, 20 SECS AT 12ATMS, AND THEN 20 SECS AT 18 ATMS; HOWEVER, BLOOD FLOW WAS OBSERVED TO BE GETTING WORSE. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE 2ND DIAGONAL WITH THE GUIDEWIRE, AND HAD DIFFICULTY CROSSING, TAKING ABOUT ONE HOUR TO CROSS. BECAUSE OF THE OVERLAPPING STENTS IN THE OSTIUM OF THE 2ND DIAGONAL, ATTEMPT TO ADVANCE THE BALLOON WERE ALSO DIFFICULT. AFTER ABOUT AN HOUR, THE QUANTUM MAVERICK BALLOON WAS ABLE TO CROSS THE LESION WITH THE ANCHOR BALLOON TECHNIQUE IN THE DISTAL PORTION OF THE LAD. THE KISSING BALLOON TECHNIQUE WAS PERFORMED FOR 25 SECS AT 8 ATMS, WITH THE MID LAD BEING DILATED WITH THE STENT BALLOON AND THE 1ST DIAGONAL BEING DILATED WITH THE QUANTUM MAVERICK. AT THIS TIME, THE BLOOD FLOW OF THE MID TO DISTAL LAD, 1ST DIAGONAL, AND 2ND DIAGONAL GOT WORSE DUE TO THROMBUS. THE MID TO DISTAL LAD WAS DILATED WITH A 2.0X10MM NON-BSC BALLOON SEVERAL TIMES AT LOW PRESSURE, INTRAVASCULAR ULTRASOUND (IVUS) DETECTED THROMBUS. ASPIRATION WAS PERFORMED, AND THE1ST DIAGONAL WAS DILATED WITH THE 2.0X10MM NON-BSC BALLOON, BUT NO BLOOD FLOW RETURNED TO THE MID TO DISTAL LAD OR THE 2ND DIAGONAL. A 3.00X24MM LIBERTE BARE METAL STENT WAS IMPLANTED INTO THE MID LAD, ASPIRATION WAS PERFORMED, BUT STILL NO BLOOD FLOW WAS RECOVERED. INTRA-AORTIC BALLOON PUMP AND PERCUTANEOUS CARDIOPULMONARY ASSIST SYSTEM (PCPS) WERE INSERTED AND THE PROCEDURE WAS STOPPED. THE PROCEDURE TOOK APPROX FOUR HOURS TO COMPLETE. MEDICATION USED DURING THE PROCEDURE INCLUDED HEPARIN. MEDICATIONS THE PT WAS TAKING INCLUDED PENALDINE, BAY ASPIRIN, NITROL, AND SIGMART. FOLLOWING THE PROCEDURE, THE PT REMAINED IN A COMA. FIVE DAYS LATER, THE PT DIED DUE TO MYOCARDIAL INFARCTION AND MULTI ORGAN FAILURE. THE CAUSE FOR THE THROMBUS IS UNK, BUT THERE IS A POSSIBILITY THAT THE PT WAS RESISTANT TO ANTICOAGULANT THERAPY, PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORP. NA 9541798

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death GUARDWIRE| SPEEDER| STENT: CYPHER| LACROSSE| SHOOTING RT| NEO'S FIELDER FC| GUIDE WIRE: RUNTHROUGH| GUIDE CATHETER: 8F MACH1 FCL4SH| EAGLEEYE| BALLOON: IKAZUCHI| THROMBUSTER| OTHER: REBIRTH