BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6170976 · Received December 13, 2016

    Report

    Report Number
    2134265-2016-11488
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 25, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME PATIENT AS MDR ID 2134265-2016-11489. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, ELECTIVE PCI WAS PERFORMED FOR ASYMPTOMATIC ISCHEMIA. THE 90% STENOSED, 3.0MMX38MM, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CASS #002. FOLLOWING PREDILATION, 3.0X20MM PROMUS ELEMENT DRUG ELUTING STENT (DES) AND A 3.0X28MM PROMUS ELEMENT DES WERE IMPLANTED. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON THE SAME DATE. IN (B)(6) 2013, CORONARY RESTENOSIS WAS CONFIRMED AND TREATED WITH PCI. THE ISSUE WAS RESOLVED THE SAME DAY. IN (B)(6) 2016, THE PATIENT DIED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821319 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death