BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2062795 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01192
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENT TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED OUTSIDE THE PATIENT. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, CONCENTRIC, DE NOVO LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS, NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, CIRCUMFLEX, AND OBTUSE MARGINAL. THE PHYSICIAN REMOVED THE PLASTIC SLEEVE FROM THE 3.00X38MM PROMUS ELEMENT STENT AND ADVANCED THE STENT DELIVERY SYSTEM (SDS) TOWARD THE LESION. THE PHYSICIAN NOTICED THE STENT WAS NOT ON THE SDS BALLOON AND THOUGHT THE STENT HAD EMBOLIZED. FLUOROSCOPY WAS PERFORMED TO LOCATE THE "LOST" STENT. AFTER "MORE THAN A HALF AN HOUR", THE STENT WAS FOUND INSIDE THE RIM OF THE PLASTIC SLEEVE WHICH HAD BEEN DISCARDED AFTER REMOVAL. THE PHYSICIAN POSTPONED THE PROCEDURE DUE TO "LOSS OF MORALE". THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 14010623

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR