BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3100388 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-03046
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2013-03045. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD ANGINA AND IN-STENT RESTENOSIS. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION 4) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS A LONG LESION EXTENDING FROM PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X16MM PROMUS ELEMENT PLUS STENT. FOLLOWING STENT PLACEMENT A GRADE A DISSECTION WAS NOTED, WHICH WAS TREATED WITH PLACEMENT OF ANOTHER 2.50X20MM PROMUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO CHEST PAIN AND WAS DIAGNOSED AS UNSTABLE ANGINA. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND WAS REFERRED FOR CARDIAC CATHETERIZATION. 90% RESTENOSIS WAS NOTED IN THE PREVIOUSLY PLACED STUDY STENT IN PROXIMAL LAD, WHICH WAS TREATED WITH THE PLACEMENT OF A 3.00X12MM NON-BSC STENT WITH 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200549 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420250 15354146

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R