BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10027080 · Received May 5, 2020

    Report

    Report Number
    2024168-2020-04120
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEVICE LABELING ISSUE WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NON-CONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DEVICE LABELING ISSUE (BOX AND POUCH LABEL DO NOT MATCH); HOWEVER, FACTORS THAT MAY CONTRIBUTE TO LABELING ISSUES (BOX AND POUCH LABEL DO NOT MATCH) INCLUDE, BUT ARE NOT LIMITED TO, MIX UP IN MANUFACTURING AND OR PACKAGING, ITEM MISPLACED DURING STORAGE, AND ERROR IN LABEL PRINTING PROCESS. IT SHOULD BE NOTED THAT THE ACCOUNT RECEIVED BOTH XIENCE SIERRA 1500300-18/9100941 AND XIENCE SIERRA 1500350-23/9091641, NEITHER LOT WAS RE-WORKED AFTER ORIGINAL MANUFACTURING, AND THE LOTS WERE MANUFACTURED A MONTH APART; THEREFORE, IT IS POSSIBLE THAT THE MIX-UP OCCURRED AT THE ACCOUNT, HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSIDE A XIENCE SIERRA 3.0 X 18 MM BOX WAS A XIENCE SIERRA 3.5 X 23 MM STENT DELIVERY SYSTEM. THE DEVICE WAS NOT USED, THERE WAS NO PATIENT INVOLVEMENT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488477 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9100941

    Patients

    Seq Age Sex Outcome Treatment
    1