BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® MUSCULAR VSD OCCLUDER

    MDR report key: 1894968 · Received November 10, 2010

    Report

    Report Number
    2135147-2010-00165
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES WERE REQUESTED, HOWEVER, ACCORDING TO THE HEALTH CARE PROVIDER, NO IMAGES WERE SAVED. THE AMPLATZER MUSCULAR VSD OCCLUDER WAS RETURNED TO AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. FOLLOWING DECONTAMINATION, THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST 8F TORQVUE LOADER WITHOUT ANY DEFORMITIES. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. OUR INVESTIGATION WAS UNABLE TO CONFIRM THE PERFORMANCE DESCRIBED AT IMPLANT; HOWEVER, WE UNDERSTAND THAT WE ARE UNABLE TO FULLY REPRODUCE ALL OF THE VARIABLES ASSOCIATED WITH THIS EVENT, INCLUDING THE LABORATORY ENVIRONMENT OR CONTRIBUTING PATIENT FACTORS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO NEW INFORMATION RECEIVED ON (B)(4), 2011 PERTAINING TO THE (B)(6), 2010 IMPLANT: DUE TO THE LENGTH OF THE CASE WITH MULTIPLE CATHETER AND SHEATH EXCHANGES AND LAB DRAWS, THE PATIENT'S HEMOGLOBIN DECREASED FROM 13 TO 10 SO THE ANESTHESIOLOGIST TRANSFUSED THE PATIENT WITH PACKED RED BLOOD CELLS. THE ESTIMATED BLOOD LOSS FOR THE ENTIRE CASE WAS APPROXIMATELY 50CC. THERE WAS NO HYPOTENSION OR HEMODYNAMIC INSTABILITY UPON COMPLETION OF THE PROCEDURE, IT WAS DECIDED THAT DUE TO THE LENGTH OF THE CASE AND DURATION THE PATIENT HAD BEEN UNDER ANESTHESIA TO LEAVE THE PATIENT INTUBATED FOR TRANSPORT TO THE CARDIAC ICU. THE PLAN WAS TO ALLOW THE PATIENT TO GET SETTLED AND THEN WEAN TO EXTUBATION OVER THE NEXT SEVERAL HOURS AS NEEDED. SHORTLY AFTER THE PATIENT ARRIVED AT THE ICU, THE PATIENT DEVELOPED DESATURATION AND BRADYCARDIA. SHE RECEIVED CHEST COMPRESSIONS AND 2 DOSES OF EPINEPHRINE IV. IT WAS DETERMINED BY THE ICU ATTENDING THAT THE ENDOTRACHEAL TUBE WAS DISLODGED DURING TRANSPORT. SHE WAS REINTUBATED BY THE ICU ATTENDING AND SUBSEQUENTLY RECOVERED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

    ACCORDING TO OUR CLINICAL DEPARTMENT, AFTER MULTIPLE ATTEMPTS AND DELIVERY SYSTEM MANIPULATIONS TO DEPLOY THE DEVICE, THE DEVICE GRADUALLY UNSCREWED FROM THE DELIVERY CABLE WHILE TRYING TO REPOSITION IT WITHIN THE VSD. THE TEE SHOWED THE LV DISC WAS PROTRUDING INTO THE RV WITH A SIGNIFICANT RESIDUAL VSD AND MODERATE TO SEVERE TRICUSPID VALVE REGURGITATION.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THIS 12MM AMPLATZER MUSCULAR VSD OCCLUDER (VSD) WAS APPROPRIATELY RELEASED FROM THE DELIVERY CABLE BUT EMBOLIZED AND BECAME CAUGHT IN THE PATIENT'S TRICUSPID VALVE CAUSING RV/RA REGURGITATION. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE SO THE DEVICE COULD BE SNARED. (ADDITIONALLY, THE PATIENT'S LEGS FORMED CLOTS DUE TO THE SIZE OF THE SHEATH REQUIRED TO RETRIEVE THE DEVICE.) IMAGING HAS BEEN REQUESTED AND THE DEVICE IS EXPECTED TO BE RETURNED. WHEN WE RECEIVE ADDITIONAL INFORMATION, AN UPDATED REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-012 M08K02-05

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention