BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3191354 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-04002
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON, THUS CONFIRMING THE REPORTED STENT DISLODGEMENT. HOWEVER, THERE WERE CRIMP MARKS VISIBLE BETWEEN THE MARKERS OF THE BALLOON, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS TAKEN OUT OF THE PLASTIC HOOP AND PRIOR TO INSERTING ON THE GUIDE WIRE FOR A STENTING PROCEDURE; THE PHYSICIAN NOTICED THE STENT WAS MISSING FROM THE BALLOON. THE STENT WAS FOUND ON THE PREPARATION TABLE. THERE WERE NO ISSUES REPORTED WITH THE PREPARATION. THE XIENCE XPEDITION SDS WAS SET ASIDE AND ANOTHER XIENCE XPEDITION SDS WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291240 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102441

    Patients

    Seq Age Sex Outcome Treatment
    1