BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 6185049 · Received December 19, 2016

    Report

    Report Number
    2134265-2016-12140
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 9, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM UPDATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-12137, 2134265-2016-12138, 2134265-2016-12139. PROMUS ELEMENT PLUS CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS DIAGNOSED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE AND CORONARY ANGIOGRAPHY WERE PERFORMED. TARGET LESION # 1 WAS LOCATED IN THE 1ST DIAGONAL WITH 90% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION # 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X24AM PROMUS ELEMENT PLUS STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 99% STENOSIS AND WAS 23MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION # 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 X 8MM AND 2.50 X 24MM PROMUS ELEMENT PLUS STUDY STENTS IN OVERLAPPING FASHION. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 3 WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. TARGET LESION # 3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 24MM PROMUS ELEMENT PLUS STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD ACUTE MYELOGENOUS LEUKEMIA AND EXPIRED ON THE SAME DAY. PER DEATH CERTIFICATE, THE PATIENT DIED DUE TO ACUTE MYELOGENOUS LEUKEMIA. AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836617 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911424270 14925440

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death