BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150818 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03554
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE XIENCE XPEDITION DEVICE, UPON REMOVAL OF THE PROTECTIVE SHEATH, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DISLODGED STENT WAS FOUND IN THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO RESISTANCE REPORTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING OR DURING REMOVAL OF THE PROTECTIVE SHEATH AND MANDREL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250932 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120341

    Patients

    Seq Age Sex Outcome Treatment
    1