BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 7779476 · Received August 13, 2018

    Report

    Report Number
    2024168-2018-06231
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 23, 2018
    Report Date
    September 10, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE DEPLOYMENT DIFFICULTY WAS NOT ABLE TO BE CONFIRMED AS THE STENT HAD ALREADY BEEN DEPLOYED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTY. THE STENT ELONGATION WAS LIKELY THE RESULT OF RETRACTING THE DELIVERY SYSTEM WITH THE STENT PARTIALLY DEPLOYED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ECCENTRIC AND DE NOVO LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD TORTUOSITY AND 85% STENOSIS. PRE-DILATATION WAS PERFORMED USING A 5.5 X 150 MM ARMADA18 BALLOON CATHETER. THEN A 5 X 150 MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND WHEN THE DEPLOYMENT LOCK WAS UNLOCKED TO DEPLOY THE STENT, AFTER SEVERAL ATTEMPTS, THE STENT WOULD NOT DEPLOY. ABNORMAL FORCE WAS APPLIED TO PULL THE SESS BACK, AND THE STENT ULTIMATELY DEPLOYED IN THE TARGET LESION WITH 20% ELONGATION, ENDING THE PROCEDURE. 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
    619473 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 7040761

    Patients

    Seq Age Sex Outcome Treatment
    1