BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2901538 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08167
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 10, 2012
    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)(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

    SAME CASE AS 2134265-2012-08168 AND 2134265-2012-08169. (B)(6). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE PLAQUE SHIFT AND RECOIL OCCURRED AND FOLLOWING THE INDEX PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE 1ST RIGHT POSTERO LATERAL BRANCH (RPL) WITH 90% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 32 MM PROMUS ELEMENT PLUS STENT, WITH 0 % RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, PRE-DILATATION OF THE TARGET LESION (1ST RPL) WAS PERFORMED WITH 2.0 X 12 MM AND 2.5 X 20 MM APEX BALLOONS DURING WHICH PLAQUE SHIFT AND RECOIL WAS NOTED. POST INDEX PROCEDURE/PRIOR TO DISCHARGE, ELEVATED CARDIAC ENZYMES VALUES WERE OBSERVED (PEAK CK-MB: 22.1 NG/ML, ULN: 6.3 NG/ML, TROPONIN: 0.39 NG/ML, ULN: 0.04 NG/ML) AND AN EVENT OF MYOCARDIAL INFARCTION WAS REPORTED, ALSO ECG WAS PERFORMED ON THE SAME DAY. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8566 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911432250 15101292

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 2.0 X 12 MM APEX BALLOON| 2.5 X 20 MM APEX BALLOON