BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11396525 · Received March 1, 2021

    Report

    Report Number
    2135147-2021-00079
    Event Type
    Injury
    Date Received
    March 1, 2021
    Report Date
    April 13, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A 20 YEAR OLD PATIENT WITH A HISTORY OF ATOPIC DERMATITIS UNDERWENT ATRIAL SEPTAL DEFECT CLOSURE AND WAS IMPLANTED WITH AN AMPLATZER SEPTAL OCCLUDER. THREE YEARS POST PROCEDURE THE PATIENT WAS DIAGNOSED WITH INFECTIVE ENDOCARDITIS AND THE DEVICE WAS EXPLANTED. VEGETATIONS WERE NOTED ON BOTH THE LEFT AND RIGHT ATRIAL SITES. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, "MOBILE VEGETATIONS ON A POORLY ENDOTHELIALIZED ATRIAL SEPTAL DEFECT CLOSURE DEVICE", WAS REVIEWED. THIS RESEARCH ARTICLE REPORTED A CASE STUDY ON A (B)(6)-YEAR OLD MAN WITH A HISTORY OF ATOPIC DERMATITIS, THAT HAD UNDERGONE PERCUTANEOUS ATRIAL SEPTAL DEFECT CLOSURE USING AN AMPLATZER SEPTAL OCCLUDER DEVICE. THREE YEARS POST PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR URGENT SURGICAL TREATMENT FOR INFECTIVE ENDOCARDITIS. THE DIAGNOSIS WAS CONFIRMED BY BLOOD CULTURES IDENTIFYING (B)(6). TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED A GIANT MOBILE MASS SUSPECTED TO REPRESENT VEGETATIONS AROUND THE DEVICE AT THE LEFT ATRIAL SITE WITHOUT RESIDUAL SHUNT. THROUGH A MEDIAN STERNOTOMY, CARDIOPULMONARY BYPASS WAS ESTABLISHED WITH ASCENDING AORTIC AND BICAVAL CANNULATIONS. AFTER CARDIOPLEGIC ARREST, THE RIGHT ATRIUM WAS OPENED AND GIANT VEGETATIONS WERE OBSERVED NOT ONLY AT THE LEFT ATRIAL SITE, BUT ALSO AT THE RIGHT ATRIAL SITE. THE DEVICE WAS REMOVED ALONG WITH THE GIANT VEGETATIONS. RADICAL DEBRIDEMENT RESULTED IN LARGE DEFECTS AT BOTH THE LEFT AND RIGHT ATRIAL WALLS. THE LEFT ATRIAL WALL WAS RECONSTRUCTED WITH A BOVINE PERICARDIAL PATCH. A SECOND PERICARDIAL PATCH WAS THEN USED TO RECONSTRUCT THE RIGHT ATRIAL SITE DEFECT, INCLUDING INTERATRIAL SEPTUM. THE REMOVED VEGETATIONS HAD MAINLY PROLIFERATED IN A POORLY ENDOTHELIALIZED AREA OF THE ATRIAL SEPTAL DEFECT CLOSURE DEVICE. POSTOPERATIVE COURSE WAS UNEVENTFUL, THE PATIENT RECEIVED INTRAVENOUS LEVOFLOXACIN THERAPY FOR FOUR WEEKS. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION WITH ORAL LEVOFLOXACIN ANTIBIOTIC THERAPY. ANTICOAGULATION THERAPY WITH WARFARIN WAS CONTINUED FOR THREE MONTHS POSTOPERATIVELY. THE ARTICLE CONCLUDED THAT AS ATOPIC DERMATITIS IS KNOWN AS A RISK FACTOR FOR INFECTIOUS ENDOCARDITIS, SURGICAL ATRIAL SEPTAL CLOSURE COULD OFFER A GOOD ALTERNATIVE TO PERCUTANEOUS DEVICE CLOSURE FOR PATIENTS WITH ATOPIC DERMATITIS. THE PRIMARY AND CORRESPONDENCE AUTHOR OF THIS ARTICLE IS HIDEKI KITAMURA, MD, PHD, 1-1-14 SUNADABASHI, HIGASHI-KU, NAGOYA, AICHI 461-0045, JAPAN WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289116 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R