BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TALISMAN PFO OCCLUDER

    MDR report key: 15287172 · Received August 24, 2022

    Report

    Report Number
    2135147-2022-00891
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    October 20, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067033314
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 25-18MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE THE RIGHT ATRIAL DISC OF THE 25-18MM AMPLATZER TALISMAN PFO OCCLUDER EXHIBITED A DEFORMATION WHEN BEING DEPLOYED. THERE WAS AN ATTEMPT TO PARTIALLY RECAPTURE AND REDEPLOY THE AMPLATZER TALISMAN PFO OCCLUDER, BUT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO FULLY RECAPTURE AND REMOVE THE 25-18MM AMPLATZER TALISMAN PFO OCCLUDER AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 28 JULY 2022, A 25-18MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE THE RIGHT ATRIAL DISC OF THE 25-18MM AMPLATZER TALISMAN PFO OCCLUDER EXHIBITED A DEFORMATION WHEN BEING DEPLOYED. THERE WAS AN ATTEMPT TO PARTIALLY RECAPTURE AND REDEPLOY THE AMPLATZER TALISMAN PFO OCCLUDER, BUT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO FULLY RECAPTURE AND REMOVE THE 25-18MM AMPLATZER TALISMAN PFO OCCLUDER AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT A 9F AMPLATZER TALISMAN DELIVERY SHEATH HAD BEEN USED AT THE TIME THE DEFORMATION OF THE 25-18MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS NOTED. THE 25-18MM AMPLATZER TALISMAN PFO OCCLUDER HAD BEEN SIZED USING A 24MM AMPLATZER SIZING BALLOON. THERE WAS NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE OCCLUDER HAD NOT BEEN MISHANDLED OR DAMAGED AT ANY POINT DURING DEVICE PREPARATION. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AT THE TIME THE DEFORMED OCCLUDER WAS DEPLOYED. THERE WAS ONE NOTED RECAPTURE OF 25-18MM AMPLATZER TALISMAN PFO OCCLUDER, BUT THE DEFORMATION PERSISTED. THE IMPLANT PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 25-18MM AMPLATZER TALISMAN PFO OCCLUDER AND THE SAME 9F AMPLATZER TALISMAN DELIVERY SHEATH WITHOUT FURTHER COMPLICATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828353 AMPLATZER TALISMAN PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-PFO-2518 8245625 05415067033314

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male