BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 5135566 · Received October 8, 2015

    Report

    Report Number
    2134265-2015-06820
    Event Type
    Death
    Date Received
    October 8, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 14, 2015
    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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-06819. (B)(4). IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY(RCA) WITH 70% STENOSIS AND WAS 18MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.20MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00MMX20MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS A CULPRIT LESION FOR ST ELEVATION MYOCARDIAL INFARCTION(STEMI) LOCATED IN THE RIGHT POSTERIOR ATRIOVENTRICULAR BRANCH (R-PAV) WITH 80% STENOSIS AND WAS 7.00MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50MMX8.00MM PROMUS ELEMENT¿ PLUS STENT, WITH 0% RESIDUAL STENOSIS. THREE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2015, THE PATIENT EXPIRED AND THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ADJUDICATION INDICATES THAT STENT THROMBOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION. IN (B)(6) 2015, THE PATIENT UNDERWENT SCHEDULED ECHO AND NUCLEAR STRESS TEST WHICH REVEALED THAT ECHO EJECTION FRACTION WAS 60% AND STRESS TEST WAS UNREMARKABLE WITH NO EVIDENCE OF ISCHEMIA. THERE WAS NO DOCUMENTATION FOR HOSPICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665640 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911608250 0015594064

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death