BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3771246 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02570
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND DIMENSIONAL INSPECTION 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. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENTS FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE 2.75X28MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS), THE STENT IMPLANT DISLODGED FROM THE BALLOON DURING PROTECTIVE SHEATH REMOVAL. REPORTEDLY, THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 2.75X28MM XIENCE XPEDITION SDS WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250253 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 210236A

    Patients

    Seq Age Sex Outcome Treatment
    1