BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202485 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04445
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THROMBOSIS AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN PROMUS ELEMENT PLUS STENT WAS IMPLANTED. THE PATIENT DEVELOPED A PROXIMAL LESION NOT RELATED TO THIS STENT. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB. DURING THE PROCEDURE A CLOT FORMED DISTALLY IN THE PREVIOUSLY DEPLOYED STENT. A NON-BSC CATHETER WAS ADVANCED TO THE LESION BUT MET RESISTANCE AT THE PROXIMAL END OF A PREVIOUSLY PLACED STENT. THEY OBSERVED THAT THE PREVIOUSLY DEPLOYED PROMUS ELEMENT PLUS STENT WAS COMPRESSED AND DECIDED TO USE A 2.5 X 8 MM NC BALLOON CATHETER AND POST-DILATED AT 12 ATMS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302662 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438250

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention