BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2943806 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00313
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER :AS THE UNIT HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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

    (B)(4) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED SIDE BRANCH CLOSURE AND A MYOCARDIAL INFARCTION. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 99% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 16 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. FOLLOWING THE PLACEMENT OF THE STENT, THE PATIENT WAS NOTED TO HAVE SOME CHEST DISCOMFORT WITH APPARENT CLOSURE OF THE DIAGONAL BRANCH AND BETA BLOCKER WAS ADDED TO MEDICATIONS. POST INDEX PROCEDURE PRIOR TO DISCHARGE, THE PATIENT WAS NOTED TO HAVE ELEVATED TROPONIN VALUE AND A MYOCARDIAL INFARCTION WAS REPORTED (PEAK TROPONIN = 2.045 NG/ML, ULN= 0.1 NG/ML). THE PATIENT WAS TREATED WITH A BETA BLOCKER. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47643 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416270 15501414

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention