BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 11599753 · Received March 31, 2021

    Report

    Report Number
    2024168-2021-02583
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 31, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648211799
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 ONE OTHER SIMILAR INCIDENT REPORTED FROM THIS LOT. HOWEVER, THERE WAS NO LOT SPECIFIC PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. IT MAY BE POSSIBLE THAT ANATOMICAL CONDITIONS (HEAVILY CALCIFIED LESION) AND THE PREVIOUSLY IMPLANTED STENT CONTRIBUTED TO A REDUCED CLEARANCE CAUSING THE RESISTANCE; HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE STEELCORE DEVICE, REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY, HEAVILY CALCIFIED LESION.A SUPERA STENT WAS SUCCESSFULLY IMPLANTED. A SECOND SUPERA STENT (S-60-040-120-P6, 0050461) WAS ALSO DEPLOYED SUCCESSFULLY. WHILE REMOVING THE SECOND SUPERA DELIVERY SYSTEM HOWEVER, RESISTANCE WAS MET BETWEEN THE SECOND SUPERA DELIVERY SYSTEM AND THE STEELCORE GUIDE WIRE (1007710-J, 0080761). THE GUIDE WIRE AND SUPERA DELIVERY SYSTEM WERE REMOVED WITHOUT FURTHER ISSUES AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT, NO INTERVENTION OR TREATMENT REQUIRED, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497870 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR S-60-040-120-P6 0050461 08717648211799

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR