BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 13958960 · Received March 31, 2022

    Report

    Report Number
    2024168-2022-03384
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LABELING ISSUE WAS 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 SIMILAR 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 AND MIX UP AT THE ACCOUNT. IT SHOULD BE NOTED THAT THE ACCOUNT RECEIVED BOTH XIENCE SIERRA 1500250-33/1102241 AND XIENCE SIERRA 1500250-38/1071441, NEITHER LOT WAS RE-WORKED AFTER ORIGINAL MANUFACTURING, AND THE LOTS WERE MANUFACTURED THREE MONTHS APART. ADDITIONALLY, THE ACCOUNT INDICATED IT IS POSSIBLE THE MIX UP OCCURRED AT THE USER FACILITY; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE SEALED PACKAGE OF A 2.5X33MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS OPENED, AND IT WAS FOUND THAT THE DEVICE INSIDE OF THE PACKAGE WAS ACTUALLY A 2.5X38MM XIENCE SIERRA DES. THE DES WAS NOT USED IN THE PATIENT AS IT WAS THE INCORRECT SIZE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 2.5X33MM XIENCE SIERRA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128638 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1102241

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown