BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895506 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00044
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    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). CATALOG# CORRECTED. EVALUATION SUMMARY: HE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DAMAGE AND RESISTANCE DURING WITHDRAWAL WAS CONFIRMED. THE RESISTANCE DURING ADVANCEMENT WAS NOT CONFIRMED HOWEVER, IS LIKELY BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL, FUNCTIONAL, AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE CROSSED THE LESION. AN ATTEMPT WAS MADE TO ADVANCE THE 3.0X15 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS); HOWEVER, IT BECAME STUCK IN THE 6F GUIDING CATHETER. A BALANCE HEAVYWEIGHT GUIDE WIRE WAS PLACED AND THE SAME PROBLEM OCCURRED. RESISTANCE WAS FELT DURING RETRACTION OF THE SDS FROM THE GUIDING CATHETER AND AFTER RETRACTION IT WAS OBSERVED THAT ONE OF THE STENT STRUTS HAD FLARED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082741

    Patients

    Seq Age Sex Outcome Treatment
    1