BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150826 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03553
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 16, 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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BALLOON LEAK WAS NOT CONFIRMED. BASED ON VISUAL AND FUNCTIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    RETURNED DEVICE ANALSYIS FOUND THAT THERE WAS NOT A LEAK IN THE BALLOON. ADDITIONALLY, THERE WAS NO DAMAGE NOTED TO THE BALLOON. THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UN-SPECIFIED PROCEDURE, THE 3.0 X 23 MM XIENCE XPEDITION STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THE SDS WOULD NOT HOLD PRESSURE. THE ACCOUNT BELIEVED THAT THERE WAS A SLOW LEAK IN THE SDS BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251200 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111641

    Patients

    Seq Age Sex Outcome Treatment
    1