BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 12968845 · Received December 9, 2021

    Report

    Report Number
    2135147-2021-00551
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806011301
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF LEFT ATRIAL DISC REMAINED DEFORMED UPON DEPLOYMENT WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE, ARTEN600038249 REV. A, "REPOSITION THE DEVICE AND DEPLOY IT AGAIN, OR REMOVE THE DEVICE FROM THE PATIENT. THE DEVICE MAY BE REPOSITIONED AND RECAPTURED UP TO 3 TIMES. DO NOT RELEASE THE DEVICE FROM THE DELIVERY CABLE IF THE DEVICE DOES NOT CONFORM TO ITS ORIGINAL CONFIGURATION OR IF DEVICE POSITION IS UNSTABLE OR INTERFERES WITH ANY ADJACENT CARDIAC STRUCTURE (SUCH AS SVC, PV, MV, CS, AO)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, A 35 MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR PROCEDURE OF A PFO CLOSURE AFTER THE PFO MEASUREMENTS WERE DETERMINED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE SCRUB TECH AND PHYSICIAN PREPARED THE PFO DEVICE ALONG WITH A 9 F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM. AFTER THE DEVICE CABLE WAS PULLED THROUGH TO BRING THE PFO DEVICE FROM THE SALINE BATH INTO THE LOADER, IT WAS NOTED THAT THERE WERE BUBBLES IN THE LOADER. THE DEVICE CABLE WAS PUSHED SO THAT THE PFO DEVICE CAME OUT OF THE LOADER AND BACK INTO THE SALINE BATH IN ATTEMPT TO REMOVE ALL THE BUBBLES FROM THE DELIVERY SYSTEM. THE DEVICE WAS PULLED OUT INTO THE SALINE BATH AND BACK INTO THE LOADER 3 TIMES IN ORDER FOR NO AIR BUBBLES TO BE SEEN. ONCE THE DEVICES WERE PREPARED, THE LOADER WAS ATTACHED TO THE DELIVERY SHEATH AND THE PFO DEVICE WAS ADVANCED INTO THE PATIENT'S BODY. THE PFO DEVICE WAS DEPLOYED, AND THE RIGHT ATRIAL DISC DID NOT LAY FLAT AS INTENDED. ATTEMPTS WERE MADE TO PUSH THE CABLE AND DELIVERY SHEATH TO TRY TO FLATTEN THE DISC WITHOUT SUCCESS. THE RIGHT ATRIAL DISC WAS RETRIEVED AND REDEPLOYED, BUT THE RIGHT ATRIAL DISC REMAINED EXPANDED AND WOULD NOT LAY FLAT. THE DECISION WAS MADE TO RE-SHEATH AND REMOVE THE PFO DEVICE FROM THE PATIENT. A 30 MM AMPLATZER PFO OCCLUDER WAS THEN SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866763 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-PFO-035 7538645 00811806011301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown