BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2803004 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06520
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    October 12, 2011
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION DEVICE. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION WITH STENTING, TIMI FLOW DEGRADATION OCCURRED. THE SUBJECT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION-2), INFERIOR STEMI AND WAS REFERRED FOR CARDIAC CATHETERIZATION. IN (B)(6) 2011, TARGET LESION #1 WAS A DE NOVO, BIFURCATED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY WITH 100% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 20 MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. ADDITIONALLY 2 NON-TARGET LESIONS LOCATED IN RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND RIGHT POSTERIOR ATRIOVENTRICULAR WERE ALSO TREATED DURING THE INDEX PROCEDURE WITH THE PLACEMENT OF 2 PROMUS ELEMENT 2.50 X 20 MM AND 2.25 MM X 12 MM NON-STUDY STENTS. DURING THE INDEX PROCEDURE WHILE TREATING THE LESION IN THE R-PDA "NO FLOW IN R-PDA" (TIMI FLOW DEGRADATION) WAS NOTED. STENT THROMBOSIS WAS NOT SUSPECTED AND A SECOND STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRAUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 14537272

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention