BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1934631 · Received December 21, 2010

    Report

    Report Number
    2134265-2010-05792
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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

    SAME CASE AS MFR REPORT#: 2134265-2010-05459. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE, STENT DISLODGEMENT AND DISSECTION OCCURRED. THE 80-90% STENOSED ECCENTRIC DE NOVO LESION MEASURING APPROXIMATELY 3.0MM IN DIAMETER AND 60MM IN LENGTH WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE. THEN A PROMUS ELEMENT OF UNKNOWN SIZE WAS IMPLANTED IN THE LESION. A 3.0X32MM PROMUS ELEMENT WAS ADVANCED TO THE LESION, BUT RESISTANCE WAS FELT AND THE DEVICE CAUGHT ON THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN PULLED HARD IN AN ATTEMPT TO REMOVE THE DEVICE AND THE SHAFT OF THE STENT DELIVERY SYSTEM FRACTURED APPROXIMATELY 10CM FROM THE DISTAL END OF THE DEVICE AND THE STENT DISLODGED. A TYPE D DISSECTION IN THE RCA ALSO OCCURRED WHILE ATTEMPTING TO REMOVE THE DEVICE. THE PATIENT WAS SENT TO BYPASS SURGERY TO REMOVE THE 10CM OF THE SHAFT, RETRIEVE THE STENT AND REPAIR THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS OCCURRED. THE PATIENT STATUS IS LISTED AS STABLE. UPON REVIEW OF THE CINE, A DISSECTION WAS NOTED AFTER PLACEMENT OF THE GUIDE CATHETER. THE PROMUS ELEMENT STENT THAT WAS INITIALLY DEPLOYED FIRST IN THE LESION WAS SHORTENED IN THE PROXIMAL THIRD OF THE STENT WHERE IT WAS INTERACTING WITH THE GUIDE CATHETER. UPON PLACEMENT OF THIS STENT THE DISSECTION APPEARS TO PROGRESS DISTALLY TO THE MID RCA. THIS DEVICE 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 UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 0.014" SKIPPER GUIDE WIRE| 3.0X32MM PROMUS ELEMENT STENT