BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1822420 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03772
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 5, 2010
    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

    DEVICE IS COMBINATION PRODUCT. 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

    (B)(6). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, DIFFICULTY WITHDRAWING AND STENT DAMAGE OCCURRED. THERE WERE TWO TARGET LESIONS TREATED AT THE INDEX PROCEDURE. THE FIRST LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.5X12MM PROMUS ELEMENT STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS A 99% STENOSED AND 14MM LONG TARGET LESION LOCATED IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. A 2.5X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, BUT IT WAS UNABLE TO CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS PULLED BACK INTO THE NON BSC GUIDE CATHETER, AND RESISTANCE WAS ENCOUNTERED. IT WAS NOTED THAT THE STENT AND CATHETER WERE NOT PERFECTLY COAXIAL, SO THE STENT WAS DAMAGED AT THE ORIFICE OF THE GUIDING CATHETER. THE SITE CONFIRMED THAT THE STENT DID NOT DISLODGE OR MOVE ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE RESULTING IN 0% RESIDUAL STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. 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 H7493911316250 13476492

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ZUMA 6F EBU GUIDE CATHETER| 2.50 X 12 MM PROMUS ELEMENT STENT