BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2211501 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03605
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT: THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY NOT THE MID LEFT ANTERIOR DESCENDING ARTERY. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.75 MM X 28 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. A 162 DAYS POST-INDEX PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED A 95% FOCAL STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY AT THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED STENT. THE STENT IS WIDELY PATENT. THE PATIENT WAS TREATED WITH PCI AND IMPLANTING A 2.75 X 8 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY NOT THE MID LEFT ANTERIOR DESCENDING ARTERY AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT 162 POST INDEX PROCEDURE THE PATIENT'S ECG WAS UNREMARKABLE AND SHE WAS NOTED TO HAVE NEGATIVE CARDIAC ENZYMES. THE PATIENT UNDERWENT A MYOCARDIAL PERFUSION STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628270 13347451

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention