BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CARDIAC PLUG

    MDR report key: 20296893 · Received September 24, 2024

    Report

    Report Number
    2135147-2024-04714
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION, CARDIAC TAMPONADE, AND HOSPITALIZATION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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. ADDITIONALLY, THE LOT WAS REVIEWED FOR SIMILAR COMPLAINTS, AND THERE IS NO INDICATION OF A LOT-SPECIFIC PRODUCT ISSUE. BASED ON THE INFORMATION RECEIVED AND CINE REVIEW, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION AND CARDIAC TAMPONADE COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED SURGICAL INTERVENTION AND HOSPITALIZATION WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS THE PATIENT WAS ADMITTED AND A PERICARDIAL WINDOW PROCEDURE WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8681119) WAS IMPLANTED SUCCESSFULLY UTILIZING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM (LOT: 9040006). PATIENT PRESENTED IN SINUS RHYTHM. DURING FOLLOW UP IN MARCH 2024, MODERATE PERICARDIAL EFFUSION WAS OBSERVED AND NO INTERVENTION WAS PERFORMED.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: CRD_1056 - ADVANCE LAA, PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: UNK) WAS IMPLANTED SUCCESSFULLY UTILIZING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM (LOT: UNK). HEPARIN AND PROTAMINE WERE GIVEN. THE PATIENT HAD A PRE-EXISTING PERICARDIAL EFFUSION. LEFT ATRIAL PRESSURE DURING THE PROCEDURE WAS 5MMHG. AFTER THE PROCEDURE, THE PATIENT HAD PERICARDIAL EFFUSION FOR SEVERAL MONTHS. ON (B)(6) 2024, THE PATIENT WAS OBSERVED TO HAVE A LARGE CIRCUMFERENTIAL PERICARDIAL EFFUSION WITH EARLY TAMPONADE. LARGEST WIDTH NEAR LEFT VENTRICLE WAS 3.5 CM. A PERICARDIAL WINDOW PROCEDURE WAS PERFORMED AND 1 LITER OF SEROSANGUINEOUS FLUID WAS DRAINED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292281 AMPLATZER CARDIAC PLUG CARDIAC PLUG NGV ABBOTT MEDICAL 8681119

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Life Threatening| H| R