BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2984054 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01188
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 RETURNED FOR EVALUATION. THE LEAK AND SHAFT BREAK/SEPARATION WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN A CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, A 2.75X12 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. REPORTEDLY, WHILE APPLYING PRESSURE TO INFLATE THE BALLOON FOR STENT DEPLOYMENT, CONTRAST WAS NOTED TO BE LEAKING FROM THE HUB AND A CRACK (BREAK) AT THE DISTAL HUB RIGHT AT THE STRAIN RELIEF TUBING WAS NOTED. DURING REMOVAL OF THE INDEFLATOR FROM THE HUB, THE DISTAL HUB RIGHT AT THE STRAIN RELIEF TUBING SEPARATED FROM THE STENT SYSTEM. THE SDS WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE. A NEW SAME SIZE RX XIENCE XPEDITION SDS WAS ADVANCED AND IMPLANTED WITHOUT ISSUE TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86361 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082241

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION: INDEFLATOR