BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2862108 · Received December 7, 2012

    Report

    Report Number
    2134265-2012-07258
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.DEVICE EVALUATED BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER AS THE INVESTIGATION INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED THROMBOTIC LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC BALLOON. IT WAS NOTED THAT A NON BSC STENT WAS PREVIOUSLY IMPLANTED IN THE PROXIMAL LAD IN (B)(6) 2012. THE PHYSICIAN ADVANCED THE 2.50X16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) THROUGH THE NON BSC STENT AS THE PHYSICIAN WANTED TO THE PLACE THE PROMUS ELEMENT PLUS STENT DISTAL TO THE PREVIOUSLY PLACED STENT. UPON DELIVERY THROUGH THE NON BSC STENT, THE PHYSICIAN FELT RESISTANCE. THE PHYSICIAN ATTEMPTED TO REMOVE THE PROMUS ELEMENT PLUS SDS FROM THE PATIENT; HOWEVER, WHEN THE SDS WAS REMOVED IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. IT WAS BELIEVED THAT THE STENT HAD DISLODGED SOMEWHERE IN THE LAD. THE PHYSICIAN ATTEMPTED TO REMOVE THE DISLODGED STENT; HOWEVER THE PATIENT WAS EVENTUALLY BROUGHT TO SURGERY TO REMOVE THE STENT. IT WAS NOTED THAT SURGERY WAS SUCCESSFUL AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416250 15514727

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention MEDTRONIC RESOLUTE STENT| ABBOTT TRACK BALLOON CATHETER