BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3142934 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03454
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL 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. 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. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: PRIOR TO USE, VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. IN THIS CASE, THE REPORTED IFU DEVIATION DID NOT CAUSE OR CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STYLET AND PROTECTIVE SHEATH WAS REMOVED FROM THE 2.25X12 MM XIENCE XPREDITION, THE STENT IMPLANT DISLODGED AND REMAINED IN THE PROTECTIVE SHEATH; HOWEVER, THIS WAS NOT OBSERVED UNTIL THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND INFLATED FOR STENT DEPLOYMENT. ON ANGIOGRAPHY, IT WAS OBSERVED THAT THERE WAS NO STENT IN THE LESION. AFTER CHECKING TO ENSURE THE STENT IMPLANT WAS NOT IN THE PATIENT SOMEWHERE, THE BACK TABLE WAS CHECKED AND THE STENT IMPLANT WAS FOUND IN THE PROTECTIVE SHEATH. ANOTHER 2.25X12 MM XIENCE XPEDITION WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243495 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101741

    Patients

    Seq Age Sex Outcome Treatment
    1