BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2350940 · Received November 29, 2011

    Report

    Report Number
    2134265-2011-05165
    Event Type
    Injury
    Date Received
    November 29, 2011
    Date of Event
    October 28, 2011
    Report Date
    October 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT.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

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE IN SEPTEMBER 2010 TREATED A 2.5X5MM 95% STENOSIS OF THE 1ST OBTUSE MARGINAL (OM1). TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF A 2.5X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. THE PATIENT RETURNED IN (B)(6) 2011 WITH LEFT CHEST PAIN RADIATING INTO THE LEFT AXILLA, SHORTNESS OF BREATH, AND NAUSEA. CARDIAC ENZYMES WERE NEGATIVE EXCEPT FOR CK-MB INDEX. EKG SHOWED SINUS RHYTHM WITHOUT ANY ST ELEVATION, T-WAVE OR Q-WAVE INVERSIONS. ANGIOGRAPHY REVEALED 95% DISTAL STENT EDGE RESTENOSIS OF THE STUDY STENT IN THE OM1. TREATMENT CONSISTED OF CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF A PROMUS STENT RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED TO BE RESOLVING AND THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL.

    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 H7493893612250 13520418

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention