BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3900411 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04173
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE KINKED/ DETACHED SHAFT WAS ABLE TO BE CONFIRMED. THE DIFFICULTY POSITIONING, REMOVING THE DEVICE AND EXCESSIVE FORCE WERE UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL AND FUNCTIONAL 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 DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION, DIFFICULT TO REMOVE, KINKED, OR DETACHMENT OF DEVICE FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RIGHT GROIN ACCESS APPROACH DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL (DIA) ARTERIES THE 2.5 X 33 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE NON-ABBOTT GUIDE CATHETER WITH TWO UNSPECIFIED GUIDE WIRES INSIDE AND RESISTANCE WAS MET WITH THE VARIOUS DEVICES. USING SOME FORCE IT WAS NOTED THAT THE SDS SHAFT BECAME KINKED DURING THE ATTEMPT TO ADVANCE THE SDS INSIDE THE GUIDE CATHETER. THE DEVICE WAS ATTEMPTED TO BE REMOVED WITH RESISTANCE NOTED AND OUTSIDE THE ANATOMY THE SHAFT SEPARATED IN THE AREA OF THE KINK. A SECOND UNSPECIFIED XIENCE SDS WAS USED IN THE PROCEDURE WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376690 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 211084A

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: EBU MEDTRONIC