BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1367373 · Received April 21, 2009

    Report

    Report Number
    2024168-2009-00686
    Event Type
    Injury
    Date Received
    April 21, 2009
    Date of Event
    December 15, 2008
    Report Date
    March 27, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT MAY REMAIN IN PT. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON BEFORE DEPLOYMENT AND COULD NOT BE LOCATED IN THE PT OR STERILE FIELD. THE PROCEDURE WAS DONE THROUGH RADIAL ARTERY ACCESS. ADDITIONAL INFORMATION RECEIVED FROM THE MEDWATCH FORM: DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE: NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CORONARY STENT DEPLOYMENT TO OSTIAL LESION OF SVG. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR AS BSC DISTRIBUTES PROMUS IN THE US AS ITS BRAND LABEL OF ABBOTT VASCULAR'S DRUG ELUTING STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability CATHETER: FORTE ES| GUIDING CATHETER: IM MANN RUNWAY| GUIDE WIRE: BOSTON SCIENTIFIC FILTER WIRE EX