BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2881912 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08028
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT MAIN CORONARY ARTERY (LMCA). A NON-BSC STENT WAS PREVIOUSLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING ENDOSCOPIC SURVEILLANCE OF THE LAD, THROMBUS WAS NOTED AND ASPIRATION WAS PERFORMED. TIMI 1 FLOW WAS NOTED AND POBA WAS PREFORMED, HOWEVER THIS DID NOT RESTORE FLOW. THE 3.5 X 16 MM PROMUS ELEMENT STENT WAS THEN DEPLOYED IN THE LMCA AND THROMBOSIS WAS ASPIRATED RESTORING TIMI 2 FLOW. POBA WAS PERFORMED IN THE LAD, DURING CROSSING ATTEMPT OF THE UNKNOWN BALLOON THE IMPLANTED STENT WAS DAMAGED DUE TO INTERACTION WITH THE GUIDE CATHETER. AN ADDITIONAL STENT WAS PLACED PROXIMAL TO THE DAMAGED STENT. PHYSICIAN NOTED THAT APPROX 8 MM OF THE PROXIMAL END OF THE STENT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316350 15446105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention