BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2833782 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07039
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 85% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SECOND OBTUSE MARGINAL VESSEL. THE PHYSICIAN WANTED TO DELIVER THE 2.50X24MM TAXUS LIBERTE STENT AT THE DISTAL PORTION OF THE RADIAL ARTERY 3CM AWAY FROM THE "APÓFISIS FESTILOIDES"; HOWEVER, THE STENT COULD NOT BE ADVANCED AND UPON REMOVAL SOME RESISTANCE WAS FELT AND THE STENT DISLODGED FROM THE BALLOON AT THE "RADIAL LEVEL". AN ATTEMPT WAS MADE TO REMOVE THE STENT BY ADVANCING A 1.5X15MM UNSPECIFIED BALLOON DISTAL TO THE STENT AND INFLATING IT TO TRAP THE STENT; HOWEVER, THE STENT WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN IMPLANTED THE STENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894024250 15127139

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention