BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3120152 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03142
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. 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 DURING PREPARATION OF A 2.75X38 RX XIENCE XPEDITION STENT DELIVERY SYSTEM, THE YELLOW PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE STENT BALLOON WAS INFLATED. NO STENT WAS VISUALIZED UNDER FLUOROSCOPY; THEREFORE, THE STENT DELIVERY SYSTEM WAS WITHDRAWN FROM THE ANATOMY. THE DISLODGED STENT WAS FOUND ON THE CATH LAB TABLE. UPON CLOSER INSPECTION OF THE PROTECTIVE SHEATH, THERE WAS A SMALL KINK NOTED. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY USING A NEW 2.75X38 RX XIENCE XPEDITION STENT SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221848 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101642

    Patients

    Seq Age Sex Outcome Treatment
    1