BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2962542 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00960
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DESCRIBE EVENT OR PROBLEM, CATALOG/MODEL #, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, IF IMPLANTED, GIVE DATE, MFG SITE NAME, DEVICE MANUFACTURE DATE. UPDATED/CORRECTED: UPN FROM (B)(4). UPDATED/CORRECTED: MANUFACTURER NAME FROM BOSTON SCIENTIFIC - (B)(4).

    Additional Manufacturer Narrative · 1

    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 FURTHER REPORTED THAT ONE 3.00X8MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE PATIENTS LEFT MAIN IN (B)(6) 2012. A SECOND PROMUS ELEMENT PLUS STENT WAS UNABLE TO CROSS DURING THIS INDEX PROCEDURE AND WAS NOT IMPLANTED. A 3.0X16MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE PATIENTS SAPHENOUS VEIN GRAFT IN (B)(6) 2013. BOTH IMPLANTED STENTS ARE IN THEIR ORIGINAL IMPLANTED LOCATIONS AND ARE PATENT. THERE IS NO RECORD OF A MIGRATED, OR "DISAPPEARED", STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE STENT "DISAPPEARED". A PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT HAD BEEN EXPERIENCING SHORTNESS OF BREATH, FATIGUE, AND SYMPTOMS OF A MYOCARDIAL INFARCTION SINCE THE IMPLANT. THE PATIENT WAS TREATED MEDICALLY FOR HER SYMPTOMS. THE PATIENT PRESENTED TO THE HOSPITAL AT A LATER DATE IN WHICH SHE IS ALLEGING THE STENT "DISAPPEARED". CT SCANS HAVE BEEN PERFORMED WHICH WERE NEGATIVE, LUNGS WERE CLEAR. PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65315 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408300 14946573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other