BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2220739 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03454
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 27, 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

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

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED THE CHEST PAIN LASTING 20 MINUTES IN DURATION. THE 99% PROXIMAL EDGE STENOSIS LOCATED IN THE LCX (TARGET LESION) WAS TREATED WITH PLACEMENT OF A 2.5 X 15 MM PROMUS DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE 99% STENOSED TARGET LESION BEING TREATED WAS 3.5MM IN DIAMETER AND 14MM LONG LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (CX). THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.5X16MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION (TVR) WITH BALLOON ANGIOPLASTY AND PLACEMENT OF TWO (2.5X18MM) PROMUS STENTS TO THE LEFT POSTERIOR DESCENDING ARTERY (L-PDA). POST TREATMENT DIAMETER STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. OF NOTE, THE SITE REPORTED THE L-PDA WAS PART OF THE CIRCUMFLEX AND THUS UNDERWENT TVR. THE PATIENT WAS DISCHARGED 1 DAY LATER. IN (B)(6) 2011 THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE PATIENT WAS NOTED TO HAVE EDGE STENOSIS OF THE STUDY STENT. THE LEFT CIRCUMFLEX (CX) WAS TREATED WITH PLACEMENT OF AN UNKNOWN DRUG ELUTING STENT. RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED 1 DAY LATER WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STUDY STENT RELATIONSHIP TO THE REVASCULARIZATION HAS CHANGED TO NOT RELATED.

    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 H7493893616350 0013012368

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention