BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1911129 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05275
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    May 7, 2010
    Report Date
    November 4, 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 COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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).

    Description of Event or Problem · 1

    TAXUS EXPRESS (B)(6) POST MARKET SURVEILLANCE STUDY. SAME CASE AS MFR REPORT #: 2134265-2010-05165. SAME PATIENT AS MFR REPORT #: 2134265-2010-00016, 2134265-2010-00017. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE TREATED TWO LESIONS. THE FIRST LESION WAS A DE NOVO 90% STENOSED, 2.75X30MM TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE-DILATATION, THE PLACEMENT OF TWO 2.75X32MM TAXUS EXPRESS2 STENTS AND POST-DILATATION RESULTING IN 0% RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN THE 1ST RIGHT POSTEROLATERAL BRANCH WAS TREATED WITH A NON BSC STENT. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON BAYASPIRIN AND PANALDINE. IN (B)(6) 2010, AT THE TWO YEAR STUDY FOLLOW UP VISIT, THE PATIENT HAD NO ANGINAL SYMPTOMS BUT RESTENOSIS WAS REVEALED IN THE DISTAL RCA. THREE DAYS LATER, THE 99% RESTENOSED, 2.5X20MM TARGET LESION WAS TREATED WITH ANGIOPLASTY RESULTING IN 25% RESIDUAL STENOSIS. THE PATIENT'S OUTCOME THE NEXT DAY WAS LISTED AS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 2.75X32 TAXUS EXPRESS2