BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 2031430 · Received March 28, 2011

    Report

    Report Number
    2135147-2011-00022
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 8MM MUSCVSD 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. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THE PATIENT HAD A LARGE MUSCULAR VSD FOR WHICH SHE UNDERWENT MUSCVSD PLACEMENT. THE POST PROCEDURE COURSE WAS COMPLICATED BY HEMODYNAMIC INSTABILITY AND A GRADUAL INCREASE IN LEFT TO RIGHT SHUNT. MUSCVSD TILTING WAS ALSO NOTED. THE PATIENT WAS REFERRED FOR SURGERY AND THE MUSCVSD WAS RETRIEVED AFTER THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND THE DEFECT WAS CLOSED. ONE CD WITH AN ECHOCARDIOGRAM OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS ECHOCARDIOGRAM WAS OF EXCELLENT QUALITY. THE PATIENT HAD A LARGE MUSCULAR VSD. IN THE ANTERIOR-POSTERIOR DIMENSIONS, THE DEFECT WAS MID-MUSCULAR WITH SOME POSTERIOR EXTENSION. IN THE SUPERIOR-INFERIOR DIMENSION, THE DEFECT WAS AT THE LEVEL OF THE INSERTION OF THE MODERATOR BAND AND MID-MUSCULAR ON THE LEFT VENTRICULAR SIDE. THERE WERE MULTIPLE COLOR JETS ON THE RV SIDE AS THE MODERATOR BAND DIVIDED THE DEFECT INTO A FEW SMALL DEFECTS. IN SHORT AXIS VIEW THE DEFECT WAS OF COMPLEX MORPHOLOGY AND MEASURED ABOUT 8-9MM WITH SIGNIFICANT TRABECULATIONS. ACCORDING TO THE REPORT, THE INITIAL DEPLOYMENT WAS UNSUCCESSFUL DUE TO SHEATH ISSUES; HOWEVER, SUBSEQUENT DEPLOYMENT WAS OPTIMAL. THE CARDIAC FUNCTION WAS FAIRLY COMPROMISED AFTER THE MUSCVSD DEPLOYMENT. THE MUSCVSD IN 4-CHAMBER VIEW LOOKED APPROPRIATE IN POSITION. THERE WAS, HOWEVER, A RESIDUAL SHUNT AT THE LOWER EDGE OF THE DEVICE. THE SHORT AXIS VIEW WAS NOT SHOWN. THE LOWER EDGE OF THE MUSCVSD APPEARED SLIGHTLY TILTED IN THE LOCATION OF THE RESIDUAL SHUNT AREA. BY REPORT, MORE AND MORE TILTING WAS SEEN (NO IMAGES PROVIDED) WITH INCREASED RESIDUAL SHUNTING AND A DECISION TO OPERATE WAS MADE. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE FOLLOWING CONCLUSIONS WERE DRAWN: THIS WAS A LARGE AND VERY COMPLEX DEFECT IN A SMALL BABY WITH A WEIGHT OF 5 KG. EXCELLENT PRE-DEVICE ECHOCARDIOGRAM INTERROGATION WAS PERFORMED. THE MUSCVSD WAS ANGULATED (TILTED) AFTER DEPLOYMENT THAT RESULTED IN A RESIDUAL SHUNT. THE RESIDUAL SHUNT WAS SMALL AND OF NO CONSEQUENCE; HOWEVER, THIS SHUNT WAS PRESENT BECAUSE PART OF THE LV DISC HAD PULLED INTO THE DEFECT. THE MUSCVSD WAS SLIGHTLY UNDERSIZED FOR A DEFECT THAT MEASURED A LITTLE MORE THAN 8MM. A 10MM MUSCVSD MAY HAVE BEEN A BETTER OPTION. AGA'S MEDICAL CONSULTANT AGREED WITH THE IMPLANTER'S THOUGHT PROCESS THAT THE MODERATOR BAND CAUSED TRACTION ON THE RV DISC WHICH FURTHER TILTED THE DEVICE AND INCREASED THE RESIDUAL SHUNT. IN THIS PATIENT, CARDIAC FUNCTION AT THE CONCLUSION OF THE PROCEDURE WAS COMPROMISED AND WITH AN INCREASE IN LEFT TO RIGHT SHUNT OVER TIME, IT DETERIORATED. SURGICAL REFERRAL FOR MUSCVSD REMOVAL AND VSD CLOSURE WAS THE JUDICIOUS DECISION FOR THIS PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE DEFECT WAS A MID MUSCULAR VSD WITH A MAXIMAL SIZE OF APPROXIMATELY 8MM BY TTE, EPICARDIAL AND TOE ECHOCARDIOGRAMS. INITIAL PLACEMENT OF THE 8MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) WAS UNSATISFACTORY DUE TO INADVERTENT POSITIONING OF THE 7F SHORT DELIVERY SHEATH THROUGH THE VSD PROPERLY. THE DELIVERY SHEATH WAS REPOSITIONED AND THE MUSCVSD WAS RE-ADVANCED WITH THE LEFT VENTRICULAR (LV) DISC IN GOOD POSITION ADJACENT TO THE INTERVENTRICULAR SEPTUM AND THE WAIST AND RIGHT VENTRICULAR (RV) DISC DEPLOYED APPROPRIATELY, THOUGH THE RV DISC WAS NOTED TO BE A LITTLE MORE BULBOUS THAN THE REFORMED LV DISC. THIS WAS ALSO THE APPEARANCE OF THE RV DISC OUTSIDE OF THE BODY AFTER IT HAD BEEN RETRIEVED AFTER THE INITIAL ATTEMPT AT IMPLANTATION. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE IN THE ICU REQUIRING THE COMMENCEMENT OF INTRAVENOUS INOTROPES AND TTE ABOUT 3 HOURS AFTER THE PROCEDURE SUGGESTED THAT THE MUSCVSD HAD BECOME TILTED WITH THE LV DISC ANGLED INTO THE VSD BUT THERE WAS NO SIGNIFICANT SHUNT AT THIS TIME. TOE A FEW HOURS LATER WAS INTERPRETED BY THE ON CALL CARDIOLOGIST AND SURGEON AS SHOWING THE MUSCVSD TO HAVE MOVED FURTHER AND THAT THERE WAS A MODEST SHUNT THAT HAD NOT BEEN PRESENT BEFORE. THE SURGEON FELT THAT THE RV DISC HAS BEEN ENTRAPPED BY MUSCLE BUNDLES IN THE RV AND BELIEVED THAT THIS CAUSED A TRACTION FORCE ON THE DEVICE MOVING IT TOWARDS THE RV CAVITY. OPEN HEART SURGERY WAS PERFORMED TO RETRIEVE THE MUSCVSD AND CLOSE THE VSD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE AND PATIENT INFORMATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    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-008 0905110356

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention