BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2771551 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-05898
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SAME CASE AS MDR ID # 2134265-2012-06012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, STENT STUCK OCCURRED. ROTABLATOR PROCEDURE WAS PERFORMED IN IMPLANTING THREE 4.00X16MM PROMUS ELEMENTS STENTS IN THE HIGHLY CALCIFIED DISTAL PART, MEDIA, AND RIGHT CORONARY ARTERY (RCA) PROXIMAL. AN ATLANTIS CATHETER SR PRO IMAGING CATHETER WAS USED TO CHECK THE PROCEDURE PERFORMANCE. IMAGES WERE TAKEN WITHOUT EXPERIENCING ANY ISSUE. DURING THE REMOVAL OF THE ATLANTIS CATHETER, THE RESISTANCE WAS FELT. THE FORCE WAS APPLIED THROUGH THE NON-BSC GUIDE CATHETER. THIS LAID THE PRESSURE OVER THE LAST IMPLANTED PROMUS ELEMENT STENT IN THE RCA PROXIMAL WHICH RESULTED IN THE SHORTENING OF THE STENT. POST-DILATATION IN THE SHORTENED STENT WAS PERFORMED TO RESOLVE. IN ADDITION, NON-BSC STENT WAS IMPLANTED OVERLAPPING THE SHORTENED PROMUS ELEMENT STENT IN PROXIMAL DA. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416400 15051892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention