BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2954828 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00763
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO CROSS/PHYSICAL RESISTANCE IN THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT BEND/KINK WAS CONFIRMED. DIFFICULT/SLOW DEFLATION WAS NOT CONFIRMED. BASED ON VISUAL 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 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. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES, AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. IT IS LIKELY THAT THE SHAFT BENT/KINKED AS A RESULT OF INADVERTENT MISHANDLING AS THE DEVICE WAS WITHDRAWN AND REINSERTED. IT IS LIKELY THAT THE BEND/KINK IN THE SHAFT COMPROMISED THE INFLATION/DEFLATION LUMEN, THEREBY CAUSING THE REPORTED DIFFICULT/SLOW DEFLATION. IT WAS REPORTED THAT AFTER THE BEND/KINK WAS STRAIGHTENED, DEFLATION WAS SUCCESSFUL.

    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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION IN THE CIRCUMFLEX ARTERY, WITH AN ACUTE BEND. THE SDS COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. THE 3.0 X 18 MM XPEDITION SDS WAS ADVANCED, BUT ALSO COULD NOT CROSS DUE TO THE ANATOMY. A 2.25 X 12 XIENCE V SDS WAS USED SUCCESSFULLY. THE 3.0 X 18 MM XIENCE XPEDITION WAS THEN ADVANCED TO THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE SDS WAS INFLATED TO AN UNKNOWN PRESSURE AND THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE DEFLATED, THE CONTRAST WOULD NOT DRAIN. A BEND WAS NOTED IN THE HYPOTUBE; THEREFORE, THE DEVICE WAS STRAIGHTENED, AND THE BALLOON WAS DEFLATED SUCCESSFULLY. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE SDS. 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
    59839 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082241

    Patients

    Seq Age Sex Outcome Treatment
    1