BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2840874 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07156
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MDR ID#2134265-2012-07313. (B)(4) TRIAL. IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION WITH STENT IMPLANTATION MYOCARDIAL INFARCTION AND ANGINA OCCURRED. THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION-IIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS DESCRIBED AS 16MM LONG, WITH A VESSEL DIAMETER OF 2.25 MM AND 80% STENOSIS. THE LESION WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 2.75X20MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. ALMOST 2 YEARS POST INDEX PROCEDURE, THE PATIENT HAS ELEVATED CARDIAC ENZYMES AND A MYOCARDIAL INFARCTION (MI) WAS REPORTED. ANGIOGRAPHY WAS PERFORMED USING A BSC IMPULSE 5F CATHETER, THE PATIENT WAS SEEN TO HAVE A FALSE ANEURYSM JUST PROXIMAL TO THE PUNCTURE SITE OF THE RADIAL ARTERY AT WRIST SITE WHICH WAS 0.4CMX0.3CM AND 1.1CMX3.1CM IN DIMENSION RESPECTIVELY. THE PATIENT PRESENTED ISCHEMIC SYMPTOMS; MEDICATION WAS GIVEN TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED 3 DAYS LATER. FOUR DAYS LATER (7 DAYS AFTER THE MI EVENT), THE PATIENT PRESENTED DUE TO ANGINA AND RIGHT RADIAL ANGIO SITE WRIST PAIN. MEDICATION WAS GIVEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. TWO WEEKS AFTER THE CORONARY ANGIOGRAPHY THE PATIENT DEVELOPED A RIGHT RADIAL PSEUDO ANEURYSM WHICH WAS TENSE AND NECROTIC FOR WHICH HE UNDERWENT A REPAIR. THE EVENT WAS CONSIDERED RESOLVE TWO DAYS LATER AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 13348444

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other