BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3855228 · Received June 9, 2014

    Report

    Report Number
    2134265-2014-03262
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 BSC ID SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DEFORMATION OCCURRED. A 3.00X32MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND DEPLOYED TO TREAT THE TARGET LESION IN THE PROXIMAL TO MID ANTERIOR DESCENDING ARTERY. AN ATLANTIS INTRAVASCULAR ULTRASOUND CATHETER WAS THEN ADVANCED; HOWEVER, THE CATHETER MADE CONTACT WITH THE PROXIMAL PORTION OF THE STENT CAUSING DEFORMATION. THE PHYSICIAN IMPLANTED ANOTHER PROMUS STENT, OVERLAPPING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334468 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432300 0016185513

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention