BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1885279 · Received October 25, 2010

    Report

    Report Number
    2024168-2010-02251
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PACKAGING AND PRODUCT NOTED THE CHIPBOARD BOX RETURNED WAS LABELED AS A 2.75 X 12MM RX XIENCE V PART NUMBER 1009540-12, LOT #9102941, (B)(4). THE FOIL POUCH AND THE TYVEK POUCH WERE BOTH LABELED AS A 2.5X12MM RX XIENCE V PART #1009539-12, LOT #0020842, (B)(4). THE SIDE ARM WAS ALSO LABELED AS A 2.5X12MM RX XIENCE LOT #0020842. THE FOIL POUCH HAD BEEN OPENED AND THE LABEL WAS PARTIALLY TORN. THE TYVEK POUCH WAS NOT OPENED. THIS INDICATES THAT THE ACTUAL DEVICE, TYVEK POUCH, AND FOIL POUCH ALL CORRESPOND TO THE SAME UNIT AND ONLY THE CHIPBOARD BOX THAT DOES NOT MATCH. A MISLABELED PRODUCT COULD RESULT FROM A MANUFACTURING DISCREPANCY OR FROM A MIX-UP AT AN AFFILIATE, DISTRIBUTOR, OR ACCOUNT. THE LOT HISTORY RECORDS FOR THE LOTS INVOLVED IN THIS INCIDENT WERE REVIEWED. PART #1009540-12, LOT #9102941 WAS MANUFACTURED IN CLONMEL WITH CHIPBOARD BOXING PERFORMED ON (B)(6) 2009. PART #1009539-12 LOT #0020842 WAS MANUFACTURED IN CLONMEL WITH CHIPBOARD BOXING PERFORMED ON (B)(6) 2010. THIS INFORMATION SUGGESTS THAT THE TWO UNITS INVOLVED IN THIS INCIDENT WERE NEVER IN MANUFACTURING OR PACKAGING AT THE SAME TIME. SHIPMENT DATA FOR THE ACCOUNT INVOLVED IN THIS INCIDENT WAS REVIEWED AND ABBOTT VASCULAR RECORDS INDICATE THAT THIS ACCOUNT WAS SENT BOTH UNITS INVOLVED IN THE POTENTIAL MIX-UP. THUS, IT APPEARS THAT THE PACKAGING MIX-UP BETWEEN THE PRODUCT LABELED ON THE CHIPBOARD BOX AND THE ACTUAL PRODUCT INSIDE THE BOX MOST LIKELY OCCURRED AT THE ACCOUNT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR MISLABELING FOR EITHER LOT. THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING THE MANUFACTURE AND PACKAGING OF THE PRODUCTS AT ABBOTT VASCULAR. SINCE THIS ACCOUNT IS IN THE UNITED STATES, THE PRODUCT IS SHIPPED AND SOLD DIRECTLY TO THE HOSPITAL WITH NO INVOLVEMENT OF AN AFFILIATE OR A DISTRIBUTOR. IT IS POSSIBLE, THAT SINCE BOTH PRODUCTS WERE SHIPPED TO THIS ACCOUNT, THAT THE PACKAGING FOR BOTH PRODUCTS WERE OPENED AND INADVERTENTLY PLACED BACK INTO THE WRONG CHIPBOARD BOXES. ALTHOUGH THE EXACT CAUSE OF HOW THE MIX-UP OCCURRED CANNOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY. PRODUCT LABELING IS SUBJECT TO A VISUAL INSPECTION AND VERIFICATION DURING MANUFACTURING OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.75 X 12 RX XIENCE V STENT DELIVERY SYSTEM WAS TO BE USED FOR THE PROCEDURE. THE CHIPBOARD BOX WAS P/N 1009540-12, LOT 9102941, (B)(4). WHEN THE SILVER FOIL WAS OPENED THE ACTUAL DEVICE INSIDE WAS A 2.5X12 RX XIENCE V, PART NUMBER 1009539-12, LOT 0020842,(B)(4). THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 9102941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA