BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2870939 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07406
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    (B)(4). DEVICE IS A 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING INTERVENTION TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE 75% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.5X28 PROMUS ELEMENT STENT TO THE LESION, BUT WAS UNABLE TO CROSS. DURING WITHDRAWAL THE DEVICE BECAME STUCK BUT WAS SUCCESSFULLY REMOVED FOLLOWING MULTIPLE REMOVAL ATTEMPTS. UPON REMOVAL IT WAS OBSERVED THAT STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 15209478

    Patients

    Seq Age Sex Outcome Treatment
    1 TAIGA EBU 3.75SH GUIDE CATHETER