BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2213063 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03231
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-03227, 2134265-2011-03228. (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. TARGET LESION ONE WAS A 2.5X12MM, 90% STENOSIS OF THE DISTAL LAD (LEFT ANTERIOR DESCENDING). TREATMENT CONSISTED OF PLACEMENT OF A 2.5X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A 2.75X24MM, 90% STENOSIS OF THE MID LAD. TREATMENT CONSISTED OF PLACEMENT OF A 2.75X16MM AND 2.5X16MM TAXUS LIBERTE STENTS RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. PER THE PATIENT'S WIFE, THE PATIENT PRESENTED IN (B)(6) 2011 WITH AN ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A TARGET VESSEL REVASCULARIZATION. THE PATIENT WAS DISCHARGED ONE DAY LATER.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED RECURRENT SHORTNESS OF BREATH AND UNDERWENT A TARGET VESSEL REINTERVENTION IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616250 13245205

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R