BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 11566040 · Received March 24, 2021

    Report

    Report Number
    2024168-2021-02366
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 6, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY TO REMOVE WAS CONFIRMED DUE TO THE DAMAGE NOTED TO THE DISTAL SHEATH. THE FAILURE TO ADVANCE COULD NOT BE TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 REVEALED NO OTHER COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES WERE LIKELY DUE TO CIRCUMSTANCES OF THE PROCEDURE. THE DIFFICULTY ADVANCING WAS LIKELY DUE TO ANATOMICAL CONDITIONS AS IT WAS REPORTED THAT THE SELF-EXPANDING STENT SYSTEM (SESS) WAS UNABLE TO CROSS THE AORTIC BIFURCATION. ADDITIONALLY, THE DAMAGE NOTED TO THE DISTAL SHEATH OF THE RETURNED SESS LIKELY OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE BIFURCATION, RESULTING IN THE INABILITY TO RETRACT THE SESS BACK INTO THE INTRODUCER SHEATH. 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 IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE LESION WAS TREATED FIRST WITH A DRUG ELUTING BALLOON (DEB). THE BIFURCATION WAS VERY STIFF. THE 7.0X20 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED BUT IT COULD NOT CROSS THE BIFURCATION TO TREAT THE LESION. THEREFORE, THE PHYSICIAN DECIDED TO LEAVE THE SESS IN THE SHEATH AS IT WAS STUCK AND COULD NOT BE MOVED. THE ENTIRE SYSTEM WAS REMOVED TOGETHER AS A UNIT. NO FURTHER TREATMENT WAS DONE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463823 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM FGE ABBOTT VASCULAR 0092262

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK ANSELL 6F 45CM SHEATH