BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4262846 · Received November 19, 2014

    Report

    Report Number
    2024168-2014-07562
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE MISLABELING WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS NOTED THE XIENCE PRIME LOT 2091241 WAS ATTEMPTED TO BE USED PAST THE EXPIRATION DATE. THE XIENCE PRIME INSTRUCTIONS FOR USE (IFU) STATES, NOTE THE USE BY (EXPIRATION) DATE ON THE PRODUCT LABEL. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND PRIOR TO USE THE 4.0 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) FOIL POUCH AND DEVICE DID NOT MATCH THE CHIPBOARD BOX LABELING. THE BOX WAS LOT NUMBER 3061341 WITH SERIAL NUMBER (B)(4) AND THE POUCH WAS LOT NUMBER 2091241 WITH SERIAL NUMBER 103858; IT WAS NOTED THE POUCH AND DEVICE WERE PASS EXPIRATION DATE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748902 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091241

    Patients

    Seq Age Sex Outcome Treatment
    1