BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2618661 · Received June 17, 2012

    Report

    Report Number
    2024168-2012-03846
    Event Type
    Malfunction
    Date Received
    June 17, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL XIENCE V IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: PHOTOS OF THE DEVICES/LABELING REVIEWED CONFIRMED THE REPORTED INFORMATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO PRODUCT QUALITY DEFICIENCY AND THE ISSUE LIKELY OCCURRED AS A RESULT OF AN INADVERTENT MIX-UP POST MANUFACTURE WHILE THE DEVICES WERE DOWNGRADED AND BEING STORED/USED AS DEMO DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO DISTRIBUTION DURING VALIDATION TESTING IT WAS NOTED THAT TWO DIFFERENT 3.0 X 28 MM XIENCE V STENT DELIVERY SYSTEM (SDS) DEVICE LABELING DID NOT MATCH. THE STENT IDENTIFICATION (ID) ON THE CHIPBOARD BOX DID NOT MATCH THE STENT ID ON THE INNER PACKAGING. DEVICE PART NUMBER 1009541-28, LOT NUMBER 1051141, POUCH (B)(4), CHIPBOARD BOX (B)(4); AND DEVICE PART NUMBER 1009541-28, LOT NUMBER 1051141, POUCH (B)(4), CHIPBOARD BOX (B)(4). THERE WAS NO PATIENT INVOLVEMENT. ALL RELEVANT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1051141

    Patients

    Seq Age Sex Outcome Treatment
    1