BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202892 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04635
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. 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). IT WAS REPORTED THAT SUBSEQUENT TO PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A SIDE BRANCH STENOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT DIAGNOSED WITH STABLE ANGINA AND UNDERWENT A CARDIAC CATHETERIZATION. TARGET LESION WAS A 90% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE DIAMETER OF 2.75MM AND A LESION LENGTH OF 25MM. THE LESION WAS PRE-DILATED USING AN UNSPECIFIED BALLOON CATHETER AND PLACEMENT OF A 3.00 X 28 MM STUDY STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED A DAY POST PROCEDURE ON DUAL ANTIPLATELET THERAPY. BASELINE CORE LAB ANGIOGRAPHY RESULTS REVEALED 60% SIDE BRANCH STENOSIS AT 1ST SEPTAL ARTERY. POST PROCEDURE ANGIOGRAPHY REVEALED 85% 'BRANCH PERCENT STENOSIS' IN 1ST SEPTAL ARTERY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED A POST PROCEDURAL MYOCARDIAL INFARCTION. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED CONSISTENT WITH THE UNIVERSAL DEFINITION OF MI (PEAK TROPONIN I: 0.19 NG/ML, ULN: 0.01NG/ML). NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301394 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428300 15661570

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other