BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 1913107 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05263
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    August 23, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - 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

    UPDATE: DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY, PATIENT CODES, COMPLAINANT ADDRESS. CORRECTION: COMPLAINANT NAME CORRECTED FROM (B)(6) TO (B)(6). (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2010-05261, 2134265-2010-05262. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND EXTENDING INTO THE MID LAD. THE TARGET LESION WAS 90% STENOSED, 3.25MM IN DIAMETER AND 38MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X38MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE LESION WAS 85% STENOSED, 2.45MM IN DIAMETER AND 10MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X12MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 3 WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY. THE LESION WAS 60% STENOSED, 2.25MM IN DIAMETER AND 7MM LONG. THE LESION WAS TREATED WITH DIRECT STENTING USING A 2.25X8MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. POST PROCEDURE, THE PATIENT EXPERIENCED ELEVATED TROPONIN ENZYMES CONSISTENT WITH A PROTOCOL DEFINED MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2010, LESION 2 AND 3 WERE TREATED IN A STAGED PROCEDURE 4 DAYS LATER. DURING THE INDEX PROCEDURE, AFTER POST DILATION OF THE STUDY STENT WITH A 3.25X15MM NON-COMPLIANT QUANTUM APEX BALLOON, THE PATIENT EXPERIENCED A VASOSPASM AND WAS TREATED WITH ADMINISTRATION OF 600 MCG OF INTRACORONARY NITROGLYCERIN. DURING THE STAGED PROCEDURE AFTER THE PLACEMENT OF THE STUDY STENTS, THE PATIENT EXPERIENCED VASOSPASM, AND WAS TREATED BY ADMINISTRATION OF 400 MCG OF INTRACORONARY NITROGLYCERIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378220 12862504

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other