BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1834311 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04279
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    March 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04278. (B)(4) IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CARDIAC CHEST PAIN. THE INDEX PROCEDURE TREATED ONE 80% STENOSED, 2.5X10MM TARGET LESION LOCATED IN THE PROXIMAL RCA (RIGHT CORONARY ARTERY). TREATMENT CONSISTED OF DIRECT STENTING WITH OVERLAPPING TAXUS LIBERTE STENTS (3.0X16MM AND 3.0X8MM) AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE ON ASPIRIN AND PRASUGREL. NINETEEN DAYS POST PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH RECURRENT CHEST DISCOMFORT. ECG AND CARDIAC ENZYMES WERE NORMAL. HOWEVER, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH FOUND A 90% STENOSIS OF THE PROXIMAL RCA. ON DAY 22, THE PATIENT UNDERWENT TREATMENT OF THE PROXIMAL RCA WITH A 3.0X12MM PROMUS STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. AT THAT TIME THE MID LAD (LEFT ANTERIOR DESCENDING) WAS ALSO TREATED WITH A 2.5X18MM PROMUS STENT AND THE PROXIMAL LAD WAS TREATED WITH A 2.5X15MM PROMUS STENT AND POST DILATION WITH GOOD RESULTS. THE PATIENT WAS DISCHARGED ON DAY 23 ON ASPIRIN AND PRASUGREL.

    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 H749389368300 12212493

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention