BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6476603 · Received April 10, 2017

    Report

    Report Number
    2024168-2017-02971
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 19, 2017
    Report Date
    April 10, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199219
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CHIPBOARD BOX AND THE FOIL POUCH WERE RETURNED FOR ANALYSIS. THE REPORTED DEVICE MARKING ISSUE WAS ABLE TO BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT A MIX-UP OCCURRED AT THE HOSPITAL. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING A CHIPBOARD BOX LABELED AS A 2.5X38MM SIZE, LOT NUMBER 6091941,RX XIENCE ALPINE DRUG-ELUTING STENT (DES) SYSTEM, IT WAS DISCOVERED THAT THE INNER FOIL POUCH WAS LABELED AS A 2.5X28MM SIZE WITH LOT NUMBER 6090641. THE INNER FOIL POUCH REMAINED SEALED AND WAS NOT OPENED. THE SITE HAD CONFIRMED THAT THE OUTER CHIPBOARD BOX WAS SEALED PRIOR TO OPENING. THERE WAS NO PATIENT INVOLVEMENT AND THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A CLINICALLY SIGNIFICANT DELAY. ANOTHER 2.5X38MM RX XIENCE ALPINE DES WAS OPENED AND USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260433 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6091941 08717648199219

    Patients

    Seq Age Sex Outcome Treatment
    1