BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3841275 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03471
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. DIFFICULTY TO POSITION THE SDS WITH THE GUIDEWIRE AND DIFFICULTY TO REMOVE THE SDS OVER THE GUIDE WIRE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE RETURNED CONDITION OF THE DEVICE. BASED ON A VISUAL/DIMENSIONAL ANALYSIS 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 OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO POSITION THE SDS WITH THE GUIDEWIRE WIRE OR FOR DIFFICULTY TO REMOVE THE DEVICE FROM THE GUIDE WIRE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.75X23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WOULD NOT TRACK OVER THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. THE DEVICE DID NOT ENTER THE PATIENT. ANOTHER 3X23 MM XIENCE XPEDITION WAS USED WITH THE SAME BMW GUIDE WIRE SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. RETURNED DEVICE ANALYSIS REVEALED A SEPARATED SOFT TIP. THE ACCOUNT WAS UNAWARE OF THE SEPARATION; HOWEVER IT WAS FURTHER REPORTED THAT THERE HAD BEEN RESISTANCE REMOVING THE DELIVERY SYSTEM FROM THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319662 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3062541

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT