BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090841 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02739
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT FRACTURE WAS NOT CONFIRMED. THE DISTAL END OF THE STENT IMPLANT WAS STRETCHED OUT PAST THE SOFT TIP AND THE DISTAL STRUTS WERE FLARED. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF A 2.75X28 RX XIENCE XPEDITION STENT DELIVERY SYSTEM, THE SPIRAL PRESENTED SEPARATED STENT STRUTS THAT WERE BENT IN DISTINCT PORTIONS, IT WAS VISUALLY EVIDENT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 2.75X28 XIENCE PRIME STENT AND A 3.0X18 XIENCE XPEDITION STENT. THE PATIENT STATUS WAS SATISFACTORY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, INVENTORY OF THE RETURNED DEVICE REVEALED THAT THE DISTAL END OF THE STENT IMPLANT WAS STRETCHED OUT PAST THE SOFT TIP. THERE WERE NO FRACTURED STRUTS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192372 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072841

    Patients

    Seq Age Sex Outcome Treatment
    1