BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833532 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04258
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-00812. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID RCA INSTEAD OF THE PROXIMAL RCA INITIALLY REPORTED. THE LESION WAS TREATED WITH OVERLAPPING 3.5X24MM AND 4.0X16MM TAXUS LIBERTE STENT INSTEAD OF ONLY THE 4.0X16MM TAXUS LIBERTE STENT INITIALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, SOURCE NOTES INDICATED THAT "WITH INITIAL BALLOON INFLATION, THERE WAS TRANSIENT SLOW FLOW THROUGHOUT THE VESSEL SYSTEM WITH SOME EVIDENT SIDE BRANCH CUTOFF." THE PATIENT WAS TREATED MEDICALLY. POST INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND ELEVATED CARDIAC ENZYMES CONSISTENT WITH MYOCARDIAL INFARCTION. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT WAS UNDER EXPANDED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 90% STENOSED, 4.0MM IN DIAMETER AND 24MM LONG. THE TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 4.0X16MM TAXUS LIBERTE STENT. DURING THE PROCEDURE, INTRAVASCULAR ULTRASOUND (IVUS) WAS USED AND CONFIRMED STENT UNDER-EXPANSION. POST-DILATION WAS PERFORMED WITH A NON-COMPLAINT BALLOON. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616400 13367974

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention