BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3223099 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04348
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGMENT WAS CONFIRMED. DIFFICULTY/RESISTANCE REMOVING THE PROTECTIVE SHEATH COULD NOT BE TESTED AS THE SHEATH WAS ALREADY REMOVED AND THE STENT IMPLANT WAS DISLODGED. 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 A XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS), THERE WAS SOME RESISTANCE FELT WITH THE REMOVAL OF THE YELLOW PROTECTIVE SHEATH AND WITH REMOVAL THE STENT DISLODGED INSIDE OF THE PROTECTIVE SHEATH. THE XIENCE XPEDITION SDS WAS SET ASIDE AND ANOTHER XIENCE XPEDITION SDS WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323640 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100341

    Patients

    Seq Age Sex Outcome Treatment
    1