BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3193539 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04499
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. 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

    (B)(4). IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, SIDE BRANCH OCCLUSION OCCURRED. THE PATIENT PRESENTED APRIL 2013 DUE TO UNSTABLE ANGINA WITH MI AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS, A LENGTH OF 24 MM, AND A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND PLACEMENT OF A 2.50 X 38 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. BASELINE CORE LAB ANGIOGRAPHY RESULT REVEALED 0% SIDE BRANCH STENOSIS AT THE FIRST DIAGONAL ARTERY HOWEVER FOLLOWING INDEX PROCEDURE, CORONARY ANGIOGRAPHY REVEALED 70% 'BRANCH PERCENT STENOSIS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292292 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438250 15542378

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other