BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3896324 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03594
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    November 21, 2013
    Report Date
    May 31, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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; 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

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CORONARY OCCLUSION OCCURRED. IN (B)(6) 2013, THE PATIENT WAS PRESENTED WITH STABLE ANGINA AND INDEX PROCEDURE WAS PERFORMED. THE 90% IN-STENT RESTENOTIC, 18.7MM X 2.05MM, ECCENTRIC, TYPE B TARGET LESION CONTAINED A LESION BEND OF < 45 DEGREES AND WAS LOCATED IN THE MODERATELY CALCIFIED, NON-TORTUOUS DISTAL CIRCUMFLEX (CX) ARTERY WITH TIMI 3 FLOW. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 24MM PROMUS ELEMENT¿ PLUS STENT AT 11 ATMOSPHERES. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. IN (B)(6) 2013, THE PATIENT DEVELOPED CORONARY OCCLUSION. THE PHYSICIAN PERFORMED ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTION (PCI). IN (B)(6) 2013, THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374710 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424220

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention