BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3163598 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03657
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. THERE WERE CRIMP MARKS VISIBLE BETWEEN THE BALLOON MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURING. WHILE REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO STENT DISLODGEMENTS OCCURRING PRIOR TO USE IN THE PATIENT WAS NOTED. FURTHER ASSESSMENT/INVESTIGATION OF THIS ISSUE PER SITE OPERATING PROCEDURES IS CURRENTLY ONGOING. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE WILL BE CONDUCTED AS APPROPRIATE AND THE PERFORMANCE OF DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE XPEDITION STENT DISLODGED WHEN THE YELLOW PROTECTIVE SHEATH WAS REMOVED. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE ENCOUNTERED DURING REMOVAL OF THE SHEATH AND EXCESSIVE FORCE WAS NOT APPLIED DURING REMOVAL OF THE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE XPEDITION WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264133 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102441

    Patients

    Seq Age Sex Outcome Treatment
    1