BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1438451 · Received April 10, 2009

    Report

    Report Number
    2024168-2009-00629
    Event Type
    Malfunction
    Date Received
    April 10, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED. ONLY THE TWO FOIL POUCHES WERE RETURNED. THE OUTER FOIL POUCH WAS RETURNED LABELED RX XIENCE 4.0 X 23 MM, PART NUMBER 1009531-23, LOT NUMBER 7073141. THE INNER FOIL POUCH WAS LABELED RX XIENCE 4.0 X 18 MM, PAT NUMBER 1009531-18, LOT NUMBER 7073041. THE TOP PORTION OF BOTH FOIL POUCHES WERE TORN OFF AND NOT RETURNED. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: MISLABELING MAY IMPACT DEVICE TRACKING. DEVICE ISSUE: MISLABELED. IT WAS REPORTED THAT THIS OCCURRED AT THE ABBOTT VASCULAR THAILAND OFFICE, DURING SCRAPPING REFERRING TO THE DES EXPIRED MATERIAL & DISPOSAL PROCEDURE. DURING THE PROCESS, THE UNIT (ALREADY EXPIRED REFERRING TO THE CARTON LABEL EXP DATE, 09/09/2008) WAS UNPACKED IN ORDER TO CUT OFF THE TIP ACCORDING TO THE PROCEDURE. IT WAS FOUND THAT THE STENT DELIVERY SYSTEM WAS PACKED IN A PLASTIC POUCH WHICH WAS PACKED IN TWO ALUMINUM POUCHES. THE INNER POUCH WAS LABELED 'XV 4.0X18MM' AND THE OUTER POUCH WAS LABELED 'XV 4.0X23MM'. OUTER CARTON OF THE UNIT HAD A LABEL WHICH WAS CORRESPONDING TO THE INNER POUCH 'XV 4.0X18MM'. THE UNIT HAD UNDERGONE THE SCRAPPING PROCESS. ADDITIONAL INFORMATION STATES, THAT IT WAS NOT NOTICED IF THE OUTER FOIL POUCH WAS SEALED; HOWEVER, BOTH THE INNER POUCH AND THE TYVEK POUCH WAS SEALED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 7073041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK