BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 745369 · Received August 4, 2006

    Report

    Report Number
    6000093-2006-01422
    Event Type
    Death
    Date Received
    August 4, 2006
    Date of Event
    June 13, 2006
    Report Date
    July 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. REPORTED BATCH 8327403 IS THE REWORK BATCH FOR 8172264. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8172264 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. A SIMILAR COMPLAINT WAS RECEIVED FOR THIS BATCH NUMBER. THIS WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS.

    Description of Event or Problem · 1

    SAME CASE AS MFR 6000093-2006-01423, -01421, AND 6000089-2006-01601, -01602, -01603, 01604, 01605. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) IMMEDIATELY POST INDEX PROCEDURE , AND DEATH FOLLOWED 2 DAYS LATER. THE INDEX PROCEDURE TREATED 4 TARGET LESIONS. THE MID RCA WAS DIRECT STENTED WITH A 3.0 X 32 MM TAXUS EXPRESS2 STENT. THE PROX LAD WAS DIRECT STENTED WITH A 2.5 X 20 MM TAXUS EXPRESS2 STENT. THE MID LAD WAS DIRECT STENTED WITH 4 OVERLAPPING TAXUS EXPRESS2 STENTS - 2.5 X 24 MM, 2.5 X 16 MM, 2.5 X 12 MM, AND 2.25 X 12MM. THE DISTAL CIRCUMFLEX WAS DIRECT STENTED WITH 2 OVERLAPPING TAXUS EXPRESS2 STENTS - 2.5 X 20MM, AND 2.5 X 12MM. THE PATIENT RECEIVED HEPARIN, TIROFIBAN AND NITRATES DURING THE PROCEDURE. RESIDUAL STENOSIS ON ALL INDEX LESIONS WAS LESS THAN 30% POST PROCEDURE. SHORTLY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ANTERIOR Q WAVE MI. THE MI WAS CONFIRMED BY ECG, AND WAS NOTED TO BE CAUSED BY A DISSECTION IN THE DISTAL LAD. THE PATIENT DIED 2 DAYS LATER. AN AUTOPSY WAS PERFORMED AND CAUSE OF DEATH WAS LISTED AS ACUTE MYOCARDIAL INFARCTION. IN THE OPINION OF THE PHYSICIAN, THE MI AND SUBSEQUENT DEATH WAS NOT RELATED TO THE STENT, BUT HAD A HIGHLY PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5 X 16 MM 8172264

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death