BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2904116 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08328
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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)(6). SAME PATIENT AS: 2134265-2013-00060. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO NON ACUTE MYOCARDIAL INFARCTION AND UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE LESION WAS 90% STENOSED, 2.5 MM IN DIAMETER AND 5 MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.5 X 12 MM PROMUS ELEMENT PLUS STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO CHEST PAIN AND WAS HOSPITALIZED THE SAME DAY. ELECTROCARDIOGRAM WAS PERFORMED 1 DAY LATER. ELEVATED CARDIAC ENZYMES WERE NOTED (PEAK CK-MB = 13.2 NG/ML, ULN = 3.6 NG/ML; PEAK TROPONIN I = 6.35 NG/ML, ULN = 0.10 NG/ML) AND WAS REPORTED TO HAVE MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, ELECTROCARDIOGRAM PERFORMED REVEALED FLATTENING T WAVES IN 3 AND AVF, ELEVATED CARDIAC ENZYMES WERE NOTED (PEAK CK-MB = 13.2 NG/ML, ULN = 3.6 NG/ML; PEAK TROPONIN I = 12.60 NG/ML, ULN = 0.10 NG/ML) AND WAS REPORTED TO HAVE MYOCARDIAL INFARCTION. THE EVENT WAS CONSIDERED NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10938 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412250 15526346

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization