BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 2638360 · Received July 3, 2012

    Report

    Report Number
    2135147-2012-00106
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 4, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K120120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRE-IMPLANT MEDICATION REGIMEN WAS ASA MG/D, POST-IMPLANT WAS ASA 100MG/D, CLOPIDOGREL 75MG/D, AND ENOXAPARIN .4ML S.Q. INITIAL MEDWATCH # 2135147-2012-00106 LISTED THE INCORRECT NUMBER, K120120 IS THE CORRECT PMA/510(K) NUMBER. THE DELIVERY SYSTEM ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO SJM FOR ANALYSIS. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM LOT SUCCESSFULLY COMPLETED THESE TESTS. CINE ANGIOGRAPHIC IMAGES RECEIVED BY SJM'S MEDICAL CONSULTANT WERE REVIEWED. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION POST ACP IMPLANT, BUT THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, AN 18 MM AMPLATZER CARDIAC PLUG (ACP) WAS IMPLANTED USING A 10F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH ((B)(4)). APPROXIMATELY 20 HOURS POST-IMPLANT, A PERFORATION WAS OBSERVED RESULTING IN PERICARDIAL TAMPONADE. NO ACUTE INJURY TO THE LEFT ATRIAL APPENDAGE (LAA) WAS OBSERVED AND THE CAUSE OF THE PERFORATION WAS UNKNOWN. THE PATIENT WAS TAKEN IN FOR SURGERY AND 450ML OF BLOOD WAS ASPIRATED. THE ACP REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-TV45X45-10F-100 1202067326

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R