BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA¿

    MDR report key: 21344287 · Received February 10, 2025

    Report

    Report Number
    2024168-2025-01455
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    UDI-DI
    08717648218248
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS WAS CONFIRMED. THE REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE WERE NOT CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: SECTION D SUSPECT MEDICAL DEVICE UPDATED FROM BRAND NAME: XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; MODEL/CATALOG: UNK XIENCE PROS; LOT: UNKNOWN; PRIMARY UDI NUMBER: UNKNOWN TO: BRAND NAME: XIENCE SIERRA¿; MODEL/CATALOG:1500225-28; LOT: 4071741; PRIMARY UDI NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A NON-TORTUOUS LESION IN THE CIRCUMFLEX. THE 2.25X28MM RX XIENCE PRO S STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER MET RESISTANCE WITH THE 6FR GUIDING CATHETER AND THE SHAFT KINKED. THE SDS WAS STUCK WITHIN THE GUIDING CATHETER THEREFORE THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A NON-TORTUOUS LESION IN THE CIRCUMFLEX. THE 2.25X28MM RX XIENCE PRO S STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER MET RESISTANCE WITH THE 6FR GUIDING CATHETER AND THE SHAFT KINKED. THE SDS WAS STUCK WITHIN THE GUIDING CATHETER THEREFORE THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784317 XIENCE SIERRA¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. 1500225-28 4071741 08717648218248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 5FR GUIDING CATHETER