BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3120644 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03182
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USE, VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE CARDIAC CATHETER LAB EMERGENTLY. DURING DEVICE PREPARATION, THE STENT CAME OFF THE BALLOON WHEN REMOVING THE MANDREL AND PROTECTIVE SHEATH. THIS WAS NOT NOTICED, SO THE STENT DELIVERY SYSTEM (SDS) WAS TAKEN TO THE LESION IN THE MID RIGHT CORONARY ARTERY AND WHEN ATTEMPTING TO DEPLOY THE STENT, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND IN THE PROTECTIVE SHEATH ON THE BACK TABLE. THE SDS WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT STENT WAS DEPLOYED IN THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222177 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112141

    Patients

    Seq Age Sex Outcome Treatment
    1