BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 788573 · Received November 17, 2006

    Report

    Report Number
    2135147-2006-00076
    Event Type
    Other
    Date Received
    November 17, 2006
    Date of Event
    July 12, 2005
    Report Date
    November 17, 2006
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE REPORTS BY A MEDICAL PROFESSIONAL RESULTED IN THE FOLLOWING FINDINGS: THE PFO WAS A TUNNEL, WITH A DIAMETER OF 14 MM AND A LENGTH OF ABOUT 20 MM. THE NARROWEST POINT (AND WAIST IN THE BALLOON) WAS AT THE LA END OF THE TUNNEL. WHEN THE DEVICE WAS DEPLOYED, THE LA DISC WAS APPROPRIATE, BUT THE RA DISC WAS DEPLOYED WITHIN THE TUNNEL BEHIND THE RETROAORTIC RIM AND THE THICK SUPERIOR VENA CAVA RIM. THUS THE EMBOLIZATION AS THE RA DISC WAS NOT TRULY IN THE RIGHT ATRIUM. DISPLACEMENT OF THE DEVICE INTO THE LA DURING THE PUSHING AND PULLING ON THE CABLE WAS A CLUE TO REMOVE THE DEVICE, RATHER THAN RELEASING IT. AGA MEDICAL IS IN COMMUNICATION WITH THE PHYSICIAN REGARDING THE TREATMENT AND HEALTH STATUS OF THIS PATIENT. THE AMPLATZER SEPTAL OCCLUDER IS A PERCUTANEOUS, TRANSCATHETER, ATRIAL SEPTAL DEFECT CLOSURE DEVICE INTENDED FOR THE OCCLUSION OF ATRIAL SEPTAL DEFECTS (ASD) IN SECUNDUM POSITION OR PATIENTS WHO HAVE UNDERGONE A FENESTRATEDD FONTAN PROCEDURE AND WHO NOW REQUIRE CLOSURE OF THE FENESTRATION (ASD IFU, INDICATIONS AND USAGE, SECTION 2). EMBOLIZED DEVICES MUST BE REMOVED (ASD IFU, WARNINGS, SECTION 4.4). THE USE OF THIS DEVICE HAS NOT BEEN STUDIED IN PATIENTS WITH PATENT FORAMEN OVALE (ASD IFU, PRECAUTIONS, SECTION 5.1). UNDER FLUOROSCOPIC AND ECHOCARDIOGRAPHIC GUIDANCE, DEPLOY THE LEFT ATRIAL DISC AND PART OF THE CONNECTING WAIST AND PULL THE DEVICE GENTLY AGAINST THE ATRIAL SEPTUM, WHICH CAN BE FELT AND ALSO OBSERVED BY ECHOCARDIOGRAPHY (ASD IFU, DIRECTIONS FOR USE, SECTION 11.3).

    Description of Event or Problem · 1

    PATIENT HAD A PFO CLOSED WITH A 14 MM ASD OCCLUDER. BALLOON SIZING WAS QUITE AGGRESSIVE STRETCHING THE PFO FROM 4-5 MM TO 14 MM, WITH A SIGNIFICANT WAIST, ALTHOUGH ONLY ON THE POSTERIOR ASPECT (THE AORTA DIDN'T HAVE MUCH RIM TO LEAVE AN IMPRINT ON THE BALLOON, AS IS OFTEN WITH THE CASE). IMPLANTATION WAS UNEVENTFUL EXCEPT FOR A FIRST ATTEMPT OF PRE-DISCHARGE PULLING AND PUSHING ON THE CABLE, IN WHICH CAUSED THE DEVICE TO SLIP INTO THE LEFT ATRIUM WITHOUT CATCHING ANY TISSUE AROUND THE AORTA. IT WAS REPOSITIONED AND A SECOND, VERY AGGRESSIVE, PULLING AND PUSHING ON THE CABLE THE DEVICE SEEMED TO CATCH ON TISSUE ON THE AORTIC SIDE AND IT RESISTED THE PUSHING TOWARDS THE LEFT ATRIUM. IN HINDSIGHT, THE DEVICE STILL WAS PROBABLY UNDERSIZED, AND A LARGER ONE WOULD HAVE INTERFERED ON THE TISSUE NEXT TO THE AORTA. THE PATIENT'S ECHOCARDIOGRAMS ON 2005 AND AGAIN NEXT MONTH MIMICKED AN AMPLATZER DEVICE IN A REMARKABLE WAY. THE LOCATION DID NOT SEEM QUITE RIGHT, BUT THERE WAS A THICKENED TWO-LAYERED SEPTUM AND ALSO TWO SMALL SPIKES ON THE SIDES, COMPATIBLE WITH THE SCREWS. ONLY WHEN THE PHYSICIAN PERFORMED A TTE AFTER HAVING FOUND OUT ON TEE THAT THE DEVICE HAD EMBOLIZED, AND AFTER REVIEWING CAREFULLY ALL THE PREVIOUS ECHOCARDIOGRAMS INCLUDING THE ONE ON THE DAY POST CATH., THE PHYSICIAN REALIZED HIS MISTAKE. BY THAT TIME, THE DEVICE WAS ALREADY IN THE ABDOMINAL AORTA FOR 9 MONTHS. IT WAS ALIGNED WITH THE WALL, NOT CAUSING ANY OBSTRUCTION TO FLOW OR OTHER MEDICAL PROBLEMS. AT THIS STAGE, ONE COULD ASSUME THAT POTENTIAL COMPLICATIONS SHOULD HAVE OCCURRED ALREADY. ALSO, RETRIEVING THE DEVICE THAT MAY BE COVERED WITH CONNECTIVE TISSUE COULD CAUSE HARM TO THE VESSEL. AFTER THE PHYSICIAN CONSULTED WITH THE MEDICAL CENTER'S VASCULAR SURGEONS, THEY DECIDED NOT TO INTERVENE AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-014 M04E18-35

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other