BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 1890910 · Received November 4, 2010

    Report

    Report Number
    2134265-2010-04922
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    November 17, 2009
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MFR REPORT #: 2134265-2009-06634. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED RESTENOSIS A SECOND TIME. THE INDEX PROCEDURE TREATED TWO LESIONS. ONE LESION IN THE MID RIGHT CORONARY ARTERY (RCA) AND ONE LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE RCA WAS TREATED WITH A 3.5X20MM TAXUS EXPRESS2 STENT. THE LAD WAS TREATED WITH AN UNKNOWN SIZE TAXUS EXPRESS2 STENT. THE PATIENT RETURNED IN (B)(6) 2009 WITH A SECOND RESTENOSIS OF THE MID RCA. THE 90% STENOSED, 3.0X10MM LESION WAS TREATED IN DECEMBER 2010 WITH CUTTING BALLOON DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS AND WAS DISCHARGED. THE INVESTIGATOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE TAXUS EXPRESS2 STENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE WITH STABLE ANGINA. THE INDEX PROCEDURE TREATED A DE NOVO, 2.47X10.4MM, 75% STENOSIS OF THE MID RCA. TREATMENT CONSISTED OF DIRECT STENTING WITH A 3.5X20MM TAXUS EXPRESS2 STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. A DE NOVO, 3.53X20.8M, 90% STENOSIS OF THE PROXIMAL LAD WAS ALSO TREATED. TREATMENT CONSISTED OF DIRECT STENTING WITH A 3.0X20MM TAXUS EXPRESS2 STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE ON PLAVIX AND BAYASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897020350 11500403

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R