BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3872653 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03813
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR SHAFT SEPARATION REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A DE NOVO, CHRONIC TOTAL OCCLUSION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, A 3.5X23 MM RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED. POST STENT IMPLANT, THE MID TO DISTAL SHAFT OF THE SDS SEPARATED INTO TWO PIECES WHEN THE BALLOON WAS JUST INSIDE OF THE 6F NON-ABBOTT GUIDING CATHETER. REPORTEDLY, NO RESISTANCE WAS FELT WITH THE GUIDING CATHETER DURING WITHDRAWAL PRIOR TO THE SEPARATION. THE SEPARATED STENT SYSTEM AND THE 6F NON-ABBOTT GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349279 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3061241

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: MEDTRONIC 6F 0.71 INNER LUMEN