BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3113668 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03357
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: INITIAL EXAMINATION NOTED THAT THE DEVICE WAS RETURNED WITH A 0.013 INCH GUIDEWIRE INSERTED THROUGH IT. IT WAS NOT POSSIBLE TO REMOVE THE GUIDEWIRE FROM THE DELIVERY SYSTEM. IT WAS NOTED THAT THE STENT HAD MOVED IN A PROXIMAL DIRECTION OFF THE BALLOON MATERIAL AND WAS SEVERELY DAMAGED. THE SHAFT OF THE DEVICE WAS SEVERELY KINKED AT 65 MM AND 76 MM PROXIMAL TO THE DISTAL TIP. OTHER SLIGHT KINKS WERE NOTED ALONG THE LENGTH OF THE HYPOTUBE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X16MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS INTRODUCED INTO A NON-BSC GUIDEWIRE. THE SDS WAS WITHDRAWN TO INJECT NICORANDIL AND CONTRAST. DURING WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON AND MOVED PROXIMAL TO THE BALLOON. UPON REMOVAL OF THE SDS WITH THE GUIDEWIRE, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEDMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X16MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS INTRODUCED INTO A NON-BSC GUIDEWIRE. THE SDS WAS WITHDRAWN TO INJECT NICORANDIL AND CONTRAST. DURING WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON AND MOVED PROXIMAL TO THE BALLOON. UPON REMOVAL OF THE SDS WITH THE GUIDEWIRE, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214438 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316270 15752614

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention