BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3142863 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03449
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. SHAFT KINK AND SHAFT SEPARATION WERE 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 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 STATES: AT ANY TIME DURING USE OF THE XIENCE XPEDITION STENT DELIVERY SYSTEM, IF THE SHAFT HAS BEEN BENT OR KINKED, DO NOT CONTINUE TO USE THE CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF EVENT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4): USE AFTER DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE ADVANCING A 2.75X15 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) VIA FEMORAL ACCESS OVER AN UNSPECIFIED GUIDE WIRE AND INTO AN UNSPECIFIED GUIDING CATHETER, THOUGH NO RESISTANCE WAS FELT AND NO FORCE WAS APPLIED, THE SDS SHAFT KINKED IN THE MIDDLE AREA OF THE SHAFT WHILE THIS AREA WAS LOCATED OUTSIDE OF THE PATIENT ANATOMY. DURING AN ATTEMPT TO STRAIGHTEN THE KINKED SHAFT, IT SEPARATED INTO TWO PIECES. THE REMAINING DISTAL PIECE OF THE SDS WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE, AS THE SEPARATION SITE WAS LOCATED OUTSIDE OF THE PATIENT ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243142 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120341

    Patients

    Seq Age Sex Outcome Treatment
    1