BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 2250223 · Received September 15, 2011

    Report

    Report Number
    2135147-2011-00126
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 25, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS AGA MEDICAL COULD NOT EVALUATE THE PRODUCT INVOLVED IN THIS EVENT SINCE IT WAS NOT RETURNED TO US. THE DELIVERY SYSTEM'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, EACH DELIVERY SYSTEM IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH LOT IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT. IMAGE REVIEW AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE, BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. CONCLUSION THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS AND MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. THE CAUSE OF THE EFFUSION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. WHEN OUR INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 12F AMPLATZER TORQVUE 45 DELIVERY SYSTEM ((B)(4)) WAS USED TO IMPLANT A 24MM AMPLATZER PI MUSCULAR VSD OCCLUDER ((B)(4)). AS THE (B)(4) WAS INSERTED IN THE PATIENT, THE (B)(4) PUNCTURED THE RIGHT VENTRICLE. THE PATIENT WAS REFERRED TO SURGERY DUE TO HIS LIFE-THREATENING INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ACCORDING TO NEW INFORMATION RECEIVED, THE DELIVERY SYSTEM WOULD NOT MAKE A BEND FROM THE RIGHT VENTRICLE TO THE LEFT VENTRICLE; IT APPEARED VIA FLUOROSCOPY AND AN ECHOCARDIOGRAM TO TRAVEL STRAIGHT FROM THE INTERNAL JUGULAR ACCESS SITE DIRECTLY THROUGH THE SUPERIOR VENA CAVA-RIGHT ATRIUM-RIGHT VENTRICLE (RV)-LEFT VENTRICLE (LV). UPON DEVICE INSERTION INTO THE LV AND SUBSEQUENT PULL BACK INTO THE RV, THE PATIENT IMMEDIATELY LOST PRESSURE AND ECHOCARDIOGRAPHY REVEALED THE PATIENT HAD AN EFFUSION. A PERFORATION OF THE LV WAS NOT CONFIRMED. NO PRODUCTS ARE EXPECTED TO BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention