BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3896973 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03723
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    SAME CASE AS MDR ID #: 2134265-2014-03724. (B)(4) STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS MYOCARDIAL INFARCTION AND UNSTABLE ANGINA. THE PATIENT WAS FOUND TO HAVE ELEVATED BIOMARKERS INDICATING ISCHEMIA PRIOR TO PROCEDURE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO MID RCA WITH 90% STENOSIS, A LENGTH OF 23 MM, AND REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 28 MM STUDY STENT. POST STUDY STENT DEPLOYMENT, GRADE A DISSECTION WAS NOTED DISTAL TO THE TARGET LESION. THE DISSECTION WAS TREATED WITH PLACEMENT OF ANOTHER 3.50 X 8 MM BAILOUT STUDY STENT RESULTING TO 0% RESIDUAL STENOSIS. ONE DAY POST-PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2014, THE PATIENT DEVELOPED CHEST PAIN. NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374832 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428350 15590725

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other