BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2983441 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01090
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 7, 2012
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE, SIDE BRANCH OCCLUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS, A LENGTH OF 12 MM, AND A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.5 X 20 MM PROMUS ELEMENT STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. CORE LAB ANGIOGRAPHY RESULT AT BASELINE NOTED 10% SIDE BRANCH STENOSIS IN 1ST SEPTAL BRANCH. BASELINE POST PROCEDURE ANGIOGRAPHY NOTED 85% BRANCH PERCENT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87827 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420350 15506152

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other