BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 22542017 · Received July 18, 2025

    Report

    Report Number
    2135147-2025-03923
    Event Type
    Death
    Date Received
    July 18, 2025
    Date of Event
    January 1, 1999
    Report Date
    July 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B2: DATE OF DEATH IS ESTIMATED. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: 15-YEAR OUTCOMES OF PFO CLOSURE IN PATIENTS WITH CRYPTOGENIC EMBOLISM: INSIGHTS FROM THE PROLONG REGISTRY.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF 15-YEAR OUTCOMES OF PFO CLOSURE IN PATIENTS WITH CRYPTOGENIC EMBOLISM WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES MELLITUS, SMOKING, HYPERLIPIDEMIA, DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, ORAL CONTRACEPTIVES, MIGRAINE, ATRIAL SEPTAL ANEURYSM. SOME OF THE COMPLICATIONS REPORTED WERE HEMORRHAGE, EMBOLISM, THROMBUS, STROKE AND DEATH; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE ARTICLE, "15-YEAR OUTCOMES OF PFO CLOSURE IN PATIENTS WITH CRYPTOGENIC EMBOLISM", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO REPORT THE EXTENDED CLINICAL OUTCOMES OF PATIENTS WHO UNDERWENT TRANSCATHETER PATENT FORAMEN OVALE (PFO) CLOSURE FOR CRYPTOGENIC EMBOLISM. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER PFO OCCLUDER, OCCLUTECH FIGULLA FLEX II, NMT CARDIOSEAL, CARDIA INTRASEPT, NMT BIOSTAR, ST. JUDE PREMERE, W.L. GORE CARDIOFORM SEPTAL OCCLUDER, COHEREX FLATSTENT, PFM NIT-OCCLUD, AND OTHER UNKNOWN. THE ARTICLE CONCLUDED THE STUDY CONFIRMED THE LONG-TERM EFFICACY AND SAFETY OF TRANSCATHETER PFO CLOSURE FOR PATIENTS WITH CRYPTOGENIC EMBOLISM AND PFO IN A REAL-WORLD SETTING. [THE PRIMARY AND CORRESPONDING AUTHOR WAS COSMO GODINO, CARDIOLOGY UNIT, SAN RAFFAELE HOSPITAL, IRCCS, VIA OLGETTINA 60, 20132 MILAN, ITALY, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM 1999 TO 2013. THE TOTAL NUMBER OF PATIENTS INVOLVED IN THE STUDY WAS 1245, OF WHICH ONLY 1114 HAD AVAILABLE DEVICE DATA. OF THE 1114 PATIENTS WITH AVAILABLE DEVICE DATA, 908 (81.5%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 47 YEARS, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, SMOKING, HYPERLIPIDEMIA, DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, ORAL CONTRACEPTIVES, MIGRAINE, ATRIAL SEPTAL ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401117 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL UNK AMPLATZER PFO OCCLUDER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death