BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA¿

    MDR report key: 23337635 · Received October 20, 2025

    Report

    Report Number
    2024168-2025-11163
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIP
    UDI-DI
    08717648224973
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED MATERIAL SEPARATION WAS ABLE TO BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS REPORTEDLY THE DEVICE WAS PREPARED BY AN UNEXPERIENCED TECH AND AS THE PACKAGING WIRE WAS REMOVED THE TIP OF THE DEVICE WAS INADVERTENTLY PULLED; THUS, TEARING OFF THE TIP. BASED ON THE REPORTED INFORMATION AND 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. D4: LOT NUMBER CORRECTED FROM UNKNOWN TO 5031961. D4: PRIMARY UDI NUMBER CORRECTED FROM (B)(4) UNKNOWN TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON UNPACKAGING THE SUPERA SELF EXPANDING STENT SYSTEM (SESS) AND DURING PREPARATION, THE WHITE TIP SEPARATED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE TIP SEPARATED WHEN THE DEVICE WAS PREPARED BY AN UNEXPERIENCED TECH AND THE PACKAGING WIRE WAS REMOVED, THUS TEARING OFF THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283972 SUPERA¿ STENT, SUPERFICIAL FEMORAL ARTERY NIP ABBOTT VASCULAR INC. 42055100-120 5031961 08717648224973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown