BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2970286 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00809
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI)STENTING TREATMENT PROCEDURE A STENT SHORTENED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD).THE PATIENT HAD SIX WEEKS AGO THE FIRST PCI WITH A PROXIMAL PROMUS ELEMENT STENT. THE PHYSICIAN WANTED TO IMPLANT A 3.0 X 38 MM PROMUS ELEMENT STENT OVERLAPPING DISTALLY TO THE STENT WHICH HAD BEEN IMPLANTED SIX WEEKS PRIOR. THE STENOSIS WAS DISTAL TO THE PREVIOUSLY PLACED STENT (ABOVE MID LAD). THE PHYSICIAN PLACED THE PROMUS ELEMENT 3.0X38MM TO OVERLAP AND DURING STENT DEPLOYMENT THE PHYSICIAN SAW THAT THE STENT PREVIOUSLY PLACED SHORTENED PROXIMALLY BY APPROXIMATELY 5 MM. THEREFORE, THERE WAS NO OVERLAPPING, BUT A GAP OF APPROXIMATELY 5 MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73961 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 15416557

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR