BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3131930 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03651
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    October 26, 2012
    Report Date
    May 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. AN ELECTROCARDIOGRAPH (ECG) INDICATED NONSPECIFIC T WAVE ABNORMALITY, AND AN EVENT OF MYOCARDIAL INFARCTION (MI) WAS REPORTED. THE CARDIAC ENZYMES WERE ELEVATED CONSISTENT WITH PROTOCOL DEFINITION OF MI. THE ELEVATED CARDIAC ENZYMES AND SIGNIFICANT CHANGES IN THE ECG WERE ASSOCIATED WITH SIDE BRANCH OCCLUSION OF THE DIAGONAL FOLLOWING THE PLACEMENT OF THE STUDY STENT.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR# 2134265-2013-03648. IT WAS REPORTED THAT FOLLOWING STENT DEPLOYMENT, ANGINA OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 80% STENOSED, 30 X 3.0MM TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE MID LAD. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF TWO PROMUS ELEMENT PLUS STENTS, A 2.50 X 24 MM AND A 2.50 X 24 MM. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. AFTER STENT DEPLOYMENT, THE PATIENT EXPERIENCED POST INFRACTION ANGINA. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED AND MEDICATION WAS ADMINISTERED. THE EVENT WAS CONSIDERED AS NOT RECOVERED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THERE WAS ON LONG LESION 30 X 3.00MM, BUT NOW IT IS REPORTED THAT THERE WERE TWO DE NOVO LESIONS, EACH 30 X 3.0MM. IT WAS FURTHER REPORTED THAT A POST DEPLOYMENT ELECTROCARDIOGRAM (ECG) REVEALED POSSIBLE LATER INFRACT AND THAT THE SIDE BRANCH OCCLUSION WAS RELATIVELY SMALL WITH THE TIMI FLOW 1 TO 2. PATIENT SYMPTOMS RAPIDLY DISSIPATED AND THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237458 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911424250 15418421

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR