BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY S

    MDR report key: 743892 · Received August 1, 2006

    Report

    Report Number
    6000093-2006-01387
    Event Type
    Death
    Date Received
    August 1, 2006
    Date of Event
    July 2, 2006
    Report Date
    July 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. THE REWORK BATCHT NUMBER 8317644 WAS USED TO LOCATE THE TOP ASSEMBLY BATCH NUMBER. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8172859 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED. THERE ARE TWO OTHER COMPLAINTS RELATED TO THIS BATCH NUMBER. COMPLAINT TYPE WAS PATIENT COMPLICATIONS (TROPONIN INCREASE).

    Description of Event or Problem · 1

    SYNTAX CLINICAL TRIAL #0250-1037 SAME CASE AS 6000093-2006-01388, 6000089-2006-01553, -01552, -01554. SAME PATIENT AS MFR # 6000093-2006-01310. IT WAS REPORTED THAT 13 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 4 TARGET VESSELS. TARGET LESION 1 WAS IN THE PROXIMAL CIRCUMFLEX AND RECEIVED A TAXUS EXPRESS2 2.5 X 12MM STENT, ALONG WITH A TAXUS EXPRESS2 2.5 X 20 MM STENT. THERE WAS OVERLAP OF THE 2 STENTS IN THIS LESION. TARGET LESION 2 WAS IN THE MID LAD AND RECEIVED A TAXUS EXPRESS2 2.75 X 32 MM STENT. LESION 3 WAS IN THE LEFT MAIN AND RECEIVED A TAXUS EXPRESS2 3.5 X 16MM STENT. LESION 4 WAS IN THE MID AND DISTAL LAD AND RECEIVED A TAXUS EXPRESS2 2.5 X 12 MM STENT. ALL LESIONS WERE DIRECT STENTED. AFTER MULTIPLE ATTEMPTS TO CROSS A LESION IN THE LAD WITH A TAXUS EXPRESS2 2.25 X 16 MM STENT, THE STENT DELIVERY SYSTEM SHAFT WAS BROKEN. THE ENTIRE SYSTEM WAS REMOVED EASILY, AND 3 ARTHOS PICO STENTS WERE PLACED INSTEAD. THE PATIENT ALSO RECEIVED HEPARIN, NITRATES, AND AN UNSPECIFIED CATECHOLAMINE DURING THE PROCEDURE. PERI PROCEDURE, THE PATIENT EXPERIENCED A PERFORATED MID LAD WHICH RESULTED IN CARDIAC TAMPONADE AND SUBSEQUENT CARDIOGENIC SHOCK. THE EVENT WAS NOTED AS RESOLVED THE FOLLOWING DAY. POST PROCEDURE, THE PT ALSO EXPERIENCED ANEMIA. TWO DAYS POST PROCEDURE THE PT WENT INTO ACUTE RENAL FAILURE. THE PATIENT EXPIRED 11 DAYS LATER. AN AUTOPSY WAS PERFORMED, AND CAUSE OF DEATH WAS LISTED AS UNTREATABLE MULTI-ORGAN FAILURE. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE DEATH AND THE TAXUS STENT. THE INDEX PROCEDURE, HOWEVER, WAS NOTED AS POSSIBLY RELATED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY S DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.5 X 16 MM 8172859

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death