BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3061960 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02428
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE CATHETER WAS RETURNED IN TWO SECTIONS DUE TO DISTAL LUMEN AND COREWIRE HAVING BEEN CUT 1 CM DISTAL TO THE GUIDEWIRE EXCHANGE PORT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PORT WAS TORN. THIS DAMAGE IS MOST LIKELY CAUSED DURING GUIDEWIRE REMOVAL. THE STENT WAS DETACHED FROM THE BALLOON AND PUSHED PROXIMALLY OVER THE CATHETER. IT IS LOOSELY ON THE DISTAL OUTER, APPROXIMATELY 2CM DISTAL TO THE POINT WHERE THE CATHETER WAS CUT. THE STENT IS BUNCHED UP. THE BALLOON WAS FULLY FOLDED WITH STENT CRIMP MARKS EVIDENT. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS. TRACES OF BLOOD WERE VISIBLE IN THE GUIDEWIRE LUMEN INDICATING THE DEVICE HAD BEEN ADVANCED OVER THE GUIDEWIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A STENT DISLODGEMENT OCCURRED. A 3.50X12MM PROMUS ELEMENT DRUG-ELUTING STENT WAS BEING PREPPED FOR USE WHEN THE STENT FELL OFF FROM THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A STENT DISLODGEMENT OCCURRED. A 3.50X12MM PROMUS ELEMENT DRUG-ELUTING STENT WAS BEING PREPPED FOR USE WHEN THE STENT FELL OFF FROM THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162312 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 15743746

    Patients

    Seq Age Sex Outcome Treatment
    1