BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM

    MDR report key: 1915106 · Received December 6, 2010

    Report

    Report Number
    2135147-2010-00175
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 6, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS DISCARDED SO WE ARE UNABLE TO PERFORM ANALYSIS TO INVESTIGATE THE REPORTED COMPLAINT. CONGENITAL ANOMALY/BIRTH DEFECT WAS CHECKED IN ERROR. "NO" SHOULD HAVE BEEN CHECKED (NOT "YES"). DELIVERY SYSTEM WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS DISCARDED SO WE ARE UNABLE TO PERFORM ANALYSIS TO INVESTIGATE THE REPORTED COMPLAINT. DELIVERY SYSTEM WAS DISCARDED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION ON NOVEMBER 8 AND WAS ADMITTED TO THE CATH LAB TO CLOSE THE PATIENT'S VENTRICULAR SEPTAL DEFECT (VSD). DUE TO THE PATIENT'S DETERIORATING CONDITION, PERCUTANEOUS INTERVENTION WAS THE SOLE OPTION TO CLOSE THE VSD AS PHYSICIANS PREDICTED A 100% MORTALITY RISK SHOULD THE PATIENT UNDERGO SURGICAL INTERVENTION. A 26MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS USED AND DEFORMED INTO A COBRA SHAPE UPON DEPLOYMENT. THE ASO WAS REMOVED AND A 28MM ASO WAS ATTEMPTED. (NOTE, THE USE OF AN ASO TO CLOSE A VSD REPRESENTS OFF-LABEL USE OF THE DEVICE.) DUE TO A KINK IN THE AMPLATZER TORQVUE 45° DELIVERY SYSTEM'S SHEATH (DTV45), THE 28MM ASO COULD NOT BE ADVANCED SO THE ASO WAS REMOVED AND THE DTV45 WAS DISCARDED. DUE TO THE PRESENCE OF INCREASING PERICARDIAL EFFUSION, WHICH WAS OBSERVED POST-PROCEDURE, THE PROCEDURE WAS ABORTED. THE PATIENT'S CONDITION WAS REPORTEDLY STABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION ON NOVEMBER 8 AND WAS ADMITTED TO THE CATH LAB TO CLOSE THE PATIENT'S VENTRICULAR SEPTAL DEFECT (VSD). DUE TO THE PATIENT'S DETERIORATING CONDITION, PERCUTANEOUS INTERVENTION WAS THE SOLE OPTION TO CLOSE THE VSD AS PHYSICIANS PREDICTED A 100% MORTALITY RISK SHOULD THE PATIENT UNDERGO SURGICAL INTERVENTION. A 26MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS USED AND DEFORMED INTO A COBRA SHAPE UPON DEPLOYMENT. THE ASO WAS REMOVED AND A 28MM ASO WAS ATTEMPTED. (NOTE, THE USE OF AN ASO TO CLOSE A VSD REPRESENTS OFF-LABEL USE OF THE DEVICE.) DUE TO A KINK IN THE AMPLATZER TORQVUE 45 DEGREES DELIVERY SYSTEM'S SHEATH (DTV45), THE 28MM ASO COULD NOT BE ADVANCED SO THE ASO WAS REMOVED AND THE DTV45 WAS DISCARDED. DUE TO THE PRESENCE OF INCREASING PERICARDIAL EFFUSION, WHICH WAS OBSERVED POST-PROCEDURE, THE PROCEDURE WAS ABORTED. THE PATIENT'S CONDITION WAS REPORTEDLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV12F45/80

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Congenital Anomaly| R 9-ASD-028| 9-ASD-028| 9-ASD-026| 9-ASD-026