BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TALISMAN PFO OCCLUDER

    MDR report key: 21160673 · Received January 15, 2025

    Report

    Report Number
    2135147-2025-00324
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 19, 2024
    Report Date
    March 19, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067033314
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE MIGRATION AFTER IMPLANT PROCEDURE WAS REPORTED. IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE DEVICE APPEARED STABLE, DESPITE HAVING THE RIGHT DISC FALLING WITHIN THE TUNNEL. FIELD INDICATED THAT THERE WAS NO DEVICE MOVEMENT NOTED ON THE FOLLOW UP TTE ECHO 4 HOURS AFTER THE PROCEDURE, AND THE DEVICE WAS STABLE ON 1 MONTH FOLLOW-UP TEE. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. CINE REVIEW WAS PERFORMED AT ABBOTT, THE PROCEDURAL ECHO IMAGING SHOWED THE PFO WITH LONG TUNNEL AND THE OCCLUDER IMPLANTATION ALONG WITH THE MINOR MIGRATION THAT OCCURRED. BASED ON THE INFORMATION RECEIVED, MIGRATION IS LIKELY DUE TO UNDER-SIZING OF DEVICE; HOWEVER, THE EXACT CAUSE OF REPORTED MIGRATION 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 WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TALISMAN DELIVERY SHEATH. DURING PROCEDURE, THE ABBOTT REPRESENTATIVE (REP) RECOMMENDED 30MM PFO OCCLUDER UPON SEEING SEPTUM WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) BASED ON LONG TUNNEL (APPROX 10MM) AND THICK SECUNDUM (APPROX 10MM) BUT PHYSICIAN INSISTED UPON A 25MM DEVICE. THE 25MM OCCLUDER WAS CONFIRMED TO BE SPLAYING THE SECUNDUM IN THE SAX VIEW WHEN DEPLOYED - BICAVAL VIEW SHOWED A MORE ENFACE APPEARANCE, FLUOROSCOPY (FLURO) SHOWED GOOD SEPARATION BETWEEN DISCS AND NO COLOR FLOW SEEN AROUND THE DEVICE. THE PHYSICIAN OPTED TO RELEASE THE DEVICE. POST PROCEDURE, APPROXIMATELY 1 MINUTE AFTER THE DEVICE WAS NOTED TO SHIFT ON FLUORO AND RE-EVALUATION ON ECHOCARDIOGRAM (ECHO) SHOWED THE RIGHT DISC TO HAVE FALLEN WITHIN THE TUNNEL IN THE SAX AND BICAVAL VIEW. THE ABBOT RERECOMMENDED TO SNARE THE DEVICE FOR REMOVAL AND UPSIZE TO THE 30MM OCCLUDER BUT PHYSICIAN FELT THAT THE DEVICE APPEARED STABLE, DESPITE HAVING THE RIGHT DISC FALLING WITHIN THE TUNNEL. LENGTHY DISCUSSION WAS HAD ABOUT EMBOLIZATION RISK AND THE RECOMMENDATION FOR REMOVING THE DEVICE, A VALSALVA WAS PERFORMED BY ANESTHESIA TO TEST DEVICE STABILITY, AND NO ADDITIONAL DEVICE MOVEMENT WAS SEEN. THERE WAS NO DEVICE MOVEMENT NOTED ON THE FOLLOW UP TTE ECHO 4 HOURS AFTER THE PROCEDURE, OR AT THE NEXT DAY FOLLOW UP TTE ECHO. ON (B)(6) 2025, A FOLLOW UP TEE WAS CONDUCTED AND IT WAS CONFIRMED THAT NO ADDITIONAL DEVICE MOVEMENT WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TALISMAN DELIVERY SHEATH. DURING PROCEDURE, THE ABBOTT REPRESENTATIVE (REP) RECOMMENDED 30MM PFO OCCLUDER UPON SEEING SEPTUM WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) BASED ON LONG TUNNEL (APPROX 10MM) AND THICK SECUNDUM (APPROX 10MM) BUT PHYSICIAN INSISTED UPON A 25MM DEVICE. THE 25MM OCCLUDER WAS CONFIRMED TO BE SPLAYING THE SECUNDUM IN THE SAX VIEW WHEN DEPLOYED - BICAVAL VIEW SHOWED A MORE ENFACE APPEARANCE, FLUOROSCOPY (FLURO) SHOWED GOOD SEPARATION BETWEEN DISCS AND NO COLOR FLOW SEEN AROUND THE DEVICE. THE PHYSICIAN OPTED TO RELEASE THE DEVICE. POST PROCEDURE, APPROXIMATELY 1 MINUTE AFTER THE DEVICE WAS NOTED TO SHIFT ON FLUORO AND RE-EVALUATION ON ECHOCARDIOGRAM (ECHO) SHOWED THE RIGHT DISC TO HAVE FALLEN WITHIN THE TUNNEL IN THE SAX AND BICAVAL VIEW. THE ABBOT RERECOMMENDED TO SNARE THE DEVICE FOR REMOVAL AND UPSIZE TO THE 30MM OCCLUDER BUT PHYSICIAN FELT THAT THE DEVICE APPEARED STABLE, DESPITE HAVING THE RIGHT DISC FALLING WITHIN THE TUNNEL. LENGTHY DISCUSSION WAS HAD ABOUT EMBOLIZATION RISK AND THE RECOMMENDATION FOR REMOVING THE DEVICE, A VALSALVA WAS PERFORMED BY ANESTHESIA TO TEST DEVICE STABILITY, AND NO ADDITIONAL DEVICE MOVEMENT WAS SEEN. THERE WAS NO DEVICE MOVEMENT NOTED ON THE FOLLOW UP TTE ECHO 4 HOURS AFTER THE PROCEDURE, OR AT THE NEXT DAY FOLLOW UP TTE ECHO. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901707 AMPLATZER TALISMAN PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 10206747 05415067033314

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male