BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6937154 · Received October 10, 2017

    Report

    Report Number
    2134265-2017-09934
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 22, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT ALL DEVICES SHIPPED FROM THE BATCH CONFORMED TO THE PREVENTIVE MEASURES / CURRENT CONTROLS. 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).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT WAS PRESENTED DUE TO SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO MID RCA WITH 80% STENOSIS, AND WAS 32 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 32 MM PROMUS ELEMENT ¿ STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH CORONARY ATHEROMATOUS HEART DISEASE AND WAS HOSPITALIZED ON THE SAME DAY. THE FOLLOWING DAY, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 99% MID STENOSIS IN RCA. SUBSEQUENTLY, THE 99% STENOSIS IN MID RCA WHICH HAD THE PREVIOUSLY STUDY DEVICE WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). POST INTERVENTION, THE RESIDUAL STENOSIS WAS 0%. FOUR DAYS AFTER, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND PATIENT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT MYOCARDIAL INFARCTION (MI) AND STENT THROMBOSIS OCCURRED. IN (B)(6) 2017, ELECTROCARDIOGRAPH (ECG) FINDINGS WERE SUGGESTIVE OF MI. THE FOLLOWING DAY, THE PATIENT WAS DIAGNOSED WITH MI UPON HOSPITALIZATION. CARDIAC ENZYME ELEVATION WAS CONSISTENT WITH PROTOCOL DEFINITION OF MI, WITH PEAK CK-TOTAL= 646 IU/L, PEAK CK-MB= 94 IU/L AND PEAK TROPONIN=3.200 NG/ML. FURTHER, ON THE SAME DAY THE PATIENT WAS DIAGNOSED WITH STENT THROMBOSIS IN DISTAL RIGHT CORONARY ARTERY (RCA). TWO DAYS LATER, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 100% PROXIMAL STENOSIS IN THE RCA. POST INTERVENTION, THERE WAS 10% RESIDUAL STENOSIS. EVENT OF STENT THROMBOSIS WAS ALSO TREATED WITH HEART THROMBOSIS THERAPY. TWO DAYS LATER, THE EVENTS OF MI AND STENT THROMBOSIS WERE CONSIDERED TO BE RECOVERED/RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714074 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332300 0015813953

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R