BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 10554644 · Received September 18, 2020

    Report

    Report Number
    2024168-2020-07834
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 27, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648211799
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IT MAY BE POSSIBLE THAT THE DISTAL SHAFT WAS ENTRAPPED OR RESTRICTED IN THE ANATOMY SUCH THAT THE RATCHET WAS UNABLE TO PROPERLY ENGAGE THE STENT TO FULLY DEPLOY; HOWEVER, THIS COULD NOT BE 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 DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100%, HEAVILY CALCIFIED AND CHRONIC TOTALLY OCCLUDED (CTO), LESION. THE VESSEL DIAMETER WAS 6.0MM AND THE LESION LENGTH WAS 100MM. A 6F 45CM SHEATH WAS ADVANCED AND THE LESION WAS PRE-DILATATION WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. A 6.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS TO BE IMPLANTED AT THE DISTAL PART OF THE LESION AND A NON-ABBOTT STENT AT THE PROXIMAL PART OF THE LESION. THE SESS WAS ADVANCED AND ON ATTEMPTING TO DEPLOY THE STENT, THE USER INADVERTENTLY PULLED THE SESS BACK AFTER 1CM HAD DEPLOYED AND THE STENT JUMPED. THE SUPERA SESS WAS REMOVED UNDER FLUOROSCOPY WITH THE STENT PARTIALLY DEPLOYED. THE NON-ABBOTT STENT WAS IMPLANTED AT THE PROXIMAL TO DISTAL PART OF LESION WERE THE SUPERA WAS PLANNED TO BE IMPLANTED, SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021036 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR S-60-040-120-P6 9031161 08717648211799

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER, PARENT 6FR,| GUIDE WIRE, V18| SHEATH:6FR X 45CM| GUIDE CATHETER, PARENT 6FR,| GUIDE WIRE, V18| SHEATH:6FR X 45CM