BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1896862 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-04961
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    March 9, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL 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

    IT WAS FURTHER REPORTED THAT 8 DAYS POST THE INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED FOR NON-CARDIAC CHEST PAIN AND TREATED WITH MEDICATION. THE PATIENT WAS DISCHARGED 5 DAYS LATER WITHOUT RESIDUAL EFFECTS AND WAS DISCHARGED ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "RELATED" TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-04960. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. THE INDEX PROCEDURE TREATED THE 99% STENOSED, 3.5X50MM TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING INTO THE MID RCA. TREATMENT CONSISTED OF PRE DILATION, THE PLACEMENT OF TWO 3.0X32MM TAXUS LIBERTE STUDY STENTS AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. FOUR DAYS LATER THE PATIENT EXPERIENCED CHEST PRESSURE OF UNKNOWN ETIOLOGY. THE PATIENT REFUSED REPEAT ANGIOGRAPHY TO DETERMINE THE ETIOLOGY OF THE CHEST PRESSURE, BUT WAS TREATED WITH MEDICATION. IN (B)(6) 2010, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. PER THE PHYSICIAN, THE STUDY STENTS WERE LISTED AS "POSSIBLY RELATED" TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632300 12267126

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 3.0X32 TAXUS LIBERTE STENT