BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO EXTEND VENOUS STENT SYSTEM

    MDR report key: 19885329 · Received August 1, 2024

    Report

    Report Number
    3017390540-2024-00005
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 9, 2024
    Report Date
    November 21, 2024
    Manufacturer
    VESPER MEDICAL INC.
    Product Code
    QAN
    PMA / PMN Number
    P230021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE PATIENT'S DOB IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCK D4: SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCKS H3/H6: THE DUO DEVICE WAS DISCARDED BY THE FACILITY; THUS, NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    BLOCK B5: CORRECTIONS WERE MADE TO BETTER CAPTURE THE REPORTED EVENT.

    Description of Event or Problem · 0

    THREE DUO STENT SYSTEM (1 HYBRID, 2 EXTEND) WERE USED IN A THROMBOTIC DISTAL COMMON FEMORAL VEIN. DURING DEPLOYMENT OF THE HYBRID STENT, THE SYSTEM JUMPED FORWARD WITH EVERY TURN OF THE WHEEL, EVEN WHEN THE PHYSICIAN WAS HOLDING BACKWARDS TENSION; HOWEVER, WAS SUCCESSFULLY COMPLETED (3017390540-2024-00003). IN THE SAME PROCEDURE, THE FIRST EXTEND WAS DEPLOYED BUT ALSO JUMPED FORWARD AND MISSED THE INTENDED MARK OF APPROX. 15 MM SHORT, REQUIRING AN ADDITIONAL STENT (3017390540-2024-00004). A SECOND EXTEND WAS DEPLOYED TO COVER THE REMAINING INTENDED MARK OF APPROX. 15 MM IN LENGTH, BUT ALSO JUMPED FORWARD . THE PROCEDURE WAS COMPLETED WITH NO FURTHER STENT REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE THE MIS-DEPLOYED STENT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    THREE DUO VENOUS STENTS (1 HYBRID, 2 EXTEND) WERE USED TO TREAT A VENOUS OBSTRUCTION. THE DUO HYBRID STENT WAS DIFFICULT TO DEPLOY, REQUIRING TWO HANDS TO TURN THE HANDLE THUMBWHEEL. THE DELIVERY SYSTEM DISTAL SEGMENT JUMPED FORWARD WITH EVERY TURN OF THE WHEEL AS THE STENT DEPLOYMENT PROGRESSED, EVEN WHEN THE PHYSICIAN WAS HOLDING BACKWARDS TENSION. HOWEVER, THE STENT DEPLOYMENT WAS SUCCESSFULLY COMPLETED (3017390540-2024-00003 NO LONGER REPORTABLE). IN THE SAME PROCEDURE, THE FIRST DUO EXTEND STENT WAS DEPLOYED TO EXTEND THERAPY TO THE COMMON FEMORAL VEIN. THE DELIVERY SYSTEM ALSO REQUIRED TWO HANDS TO DEPLOY AND JUMPED FORWARD WITH EVERY TURN OF THE THUMBWHEEL. THE STENT DEPLOYMENT MISSED SHORT OF THE INTENDED CAUDAL ANATOMICAL MARK BY APPROX. 15 MM (3017390540-2024-00004). A SECOND DUO EXTEND STENT WAS DEPLOYED TO COVER THE REMAINING PORTION OF THE VEIN BUT ALSO DEPLOYED SHORT OF THE INTENDED CAUDAL ANATOMICAL MARK BY APPROX. 0.5 CM (5 MM) IN LENGTH (3017390540-2024-00005). THE PROCEDURE WAS COMPLETED WITH NO FURTHER STENT REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE MIS-DEPLOYED STENT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025433 DUO EXTEND VENOUS STENT SYSTEM STENT, ILIAC VEIN QAN VESPER MEDICAL INC. N1201412009120 353698

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female ASAHI 0.035" GUIDEWIRE.| TERUMO: 11F PINNACLE INTRODUCER SHEATH.