BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 6414217 · Received March 17, 2017

    Report

    Report Number
    2135147-2017-00041
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    July 10, 2017
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY THE ABBOTT EROSION BOARD AND CONFIRMED THAT EROSION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION COME FROM "CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS" 89:502¿504 (2017). TITLE: "LATE TISSUE EROSION AFTER TRANSCATHETER CLOSURE OF AN ATRIAL SEPTAL DEFECT." THE PATIENT'S 21 MM SECUNDUM ASD WAS PERCUTANEOUSLY REPAIRED WITH A 22 MM AMPLATZER SEPTAL OCCLUDER (ASO). THE PATIENT HAD AN UNEVENTFUL COURSE POST-PROCEDURE. APPROXIMATELY 4 YEARS POST PROCEDURE, THE PATIENT PRESENTED WITH SUDDEN ONSET SHARP RETROSTERNAL CHEST PAIN ASSOCIATED WITH DYSPNEA. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE CHEST REVEALED A LARGE PERICARDIAL EFFUSION, CONSISTENT WITH HEMOPERICARDIUM. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) RE-DEMONSTRATED THE LARGE PERICARDIAL EFFUSION AND CONFIRMED TAMPONADE PHYSIOLOGY. ADDITIONALLY, A LARGE THROMBUS ATTACHED TO THE RIGHT ATRIAL SURFACE OF THE ASO WAS NOTED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM EMERGENTLY, WHERE THE ASO WAS FOUND TO HAVE ERODED THROUGH THE LEFT ATRIAL WALL LEADING TO HEMOPERICARDIUM. THE ASO AND ASSOCIATED THROMBUS WERE REMOVED. THE PERICARDIAL COLLECTION WAS EVACUATED AS WELL. THE LEFT ATRIAL PERFORATION WAS SURGICALLY REPAIRED AND THE SECUNDUM ASD WAS CLOSED BY PATCH REPAIR. THE PATIENT HAD AN UNEVENTFUL POST-OPERATIVE COURSE AND WAS DISCHARGED HOME 5 DAYS AFTER HIS PRESENTATION. ACCORDING TO THE ARTICLE, LATE TISSUE EROSION LEADING TO PERFORATION AND CARDIAC TAMPONADE SHOULD BE SHOULD BE SUSPECTED IN PATIENTS WITH A REMOTE HISTORY OF TRANSCATHETER ASD CLOSURE WITH AN ASO DEVICE WHO PRESENT WITH ACUTE CHEST PAIN OR DYSPNEA AND SIGNS OF HEMODYNAMIC INSTABILITY. A HIGH INDEX OF SUSPICION IS CRUCIAL FOR THE PROMPT IDENTIFICATION AND MANAGEMENT OF THIS POTENTIALLY FATAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195587 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-022

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R