BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 969757 · Received December 21, 2007

    Report

    Report Number
    6000089-2007-01741
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    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 OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING RECORD CANNOT BE COMPLETED AS THE BATCH NUMBER IS UNK AT THIS TIME. A SIMILAR COMPLAINT REVIEW CANNOT BE COMPLETED AS THE BATCH NUMBER IS UNK AT THIS TIME. THE ROOT CAUSE OF THE COMPLAINT IS UNK.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #6000089-2007-01740. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, DEATH OCCURRED. THE 90% STENOSED TARGET LESION WAS IN THE PROXIMAL TO MID PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS TREATED WITH 1.25MM AND 1.55MM ROTABLATOR BURRS. A NON-BSC GUIDEWIRE WAS ADVANCED TO THE LAD AND A PT2 GUIDEWIRE WAS INSERTED INTO THE 1ST DIAGONAL (DIAG). A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED DISTALLY WITH A 2.75X32MM TAXUS EXPRESS2 DES IMPLANTED PROXIMALLY. THE PT2 GUIDEWIRE WAS EXCHANGED FOR A NON-BSC GUIDEWIRE. A NON-BSC BALLOON CATHETER WAS INSERTED TO ATTEMPT ANGIOPLASTY AT THE 1ST DIAG; HOWEVER, THE DISTAL SIDE OF THE VESSEL "DISAPPEARED." THE PT COMPLAINED OF CHEST PAIN, WHICH THE PHYSICIAN FELT WAS IN THE "ALLOWABLE RANGE." INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED GOOD STENT APPOSITION. THE LAD WAS IMPROVED. THERE WAS "NO PROBLEM" NOTED WITH THE PT'S CPK AND CPT VALUES. FOUR DAYS LATER, REEVALUATION OF THE PT'S CORONARY ANATOMY WAS SCHEDULED PRIOR TO DISCHARGE. THE PROCEDURE WAS UNABLE TO BE PERFORMED AS THE PT COLLAPSED, CARDIAC ARREST OCCURRED AND THE PT DIED IN THE PROCEDURE ROOM. THE CAUSE OF DEATH WAS REPORTED AS "HEART RUPTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.5X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death RYUJIN BALLOON (TERUMO)| FIELDER GUIDEWIRE (ASAHI INTECC)| HIGH-TORQUE BALANCE UNIVERSAL GUIDEWIRE (ABBOTT)