BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2870331 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07436
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 14, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2012-07494. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PROCEDURE PLACED A 2.5X12MM PROMUS ELEMENT PLUS STENT IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 2.5X16MM PROMUS ELEMENT PLUS STENT IN THE PROXIMAL LAD ARTERY. SIX DAYS LATER THE PATIENT PRESENTED WITH CLOTTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416250 15155201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention