BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6000956 · Received October 5, 2016

    Report

    Report Number
    2134265-2016-08766
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. FEMORAL ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER IMPLANTING A 3.50X24MM PROMUS ELEMENT ¿ DRUG - ELUTING STENT (DES), POST DILATATION WAS PERFORMED WITH A NON-BSC BALLOON CATHETER. HOWEVER, A LONG DISSECTION STARTING FROM THE DISTAL EDGE OF THE DEPLOYED STENT WAS NOTED. A 2.75X32MM PROMUS ELEMENT ¿ DES WAS THEN IMPLANTED OVERLAPPING THE PREVIOUSLY IMPLANTED 3.50X24MM PROMUS ELEMENT ¿ DES TO COVER THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652167 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324350 18782042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention