BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 25071494 · Received May 4, 2026

    Report

    Report Number
    2135147-2026-02948
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    March 1, 2005
    Report Date
    May 4, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    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

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER PFO OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, AND STROKE. COMPLICATIONS REPORTED INCLUDED PATIENT DEVICE INTERACTION PROBLEM (RESIDUAL SHUNT), ATRIAL FIBRILLATION, TACHYCARDIA; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED IFU DEVIATION/OFF-LABEL USE WAS ASSOCIATED WITH DEVICE IMPLANT IN THE ATRIAL SEPTAL DEFECT. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: TRANSSEPTAL PUNCTURE AND CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH ATRIAL SEPTAL OCCLUDER DEVICES: PROCEDURAL TECHNIQUES AND OUTCOME. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSSEPTAL PUNCTURE AND CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH ATRIAL SEPTAL OCCLUDER DEVICES: PROCEDURAL TECHNIQUES AND OUTCOMES", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE A PRACTICAL, CASE-BASED APPROACH TO TRANSSEPTAL PUNCTURE IN PATIENTS WITH ATRIAL SEPTAL OCCLUDER (ASO) DEVICES AND PROCEDURAL OUTCOMES. THE DEVICES INCLUDED IN THE STUDY WERE AMPLATZER SEPTAL OCCLUDER, AMPLATZER CRIBIFORM, AMPLATZER PFO OCCLUDER, FIGULLA FLEX II SEPTAL OCCLUDER, AND GORE CARDIOFORM ASD OCCLUDER. THE ARTICLE CONCLUDED THAT TRANSSEPTAL PUNCTURE AND ATRIAL FIBRILLATION ABLATION CAN BE PERFORMED SAFELY AND EFFECTIVELY IN PATIENTS WITH ASO DEVICES. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOJI NAKAGAWA, DEPARTMENT OF CARDIOVASCULAR MEDICINE, OKAYAMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, DENTISTRY AND PHARMACEUTICAL SCIENCES, OKAYAMA, JAPAN, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT ASO DEVICE IMPLANTATION FROM 01 MARCH 2005 TO 30 SEPTEMBER 2025. A TOTAL OF 28 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 75% (21) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 67 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28927 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL UNK AMPLATZER PFO OCCLUDER

    Patients

    Seq Age Sex Outcome Treatment
    1