BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1523080 · Received November 9, 2009

    Report

    Report Number
    2135147-2009-00150
    Event Type
    Injury
    Date Received
    November 9, 2009
    Date of Event
    October 20, 2009
    Report Date
    May 25, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL FILE A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THE PRE-PROCEDURAL TTE EVALUATED THE HIGH SECUNDUM ASD IN MULTIPLE VIEWS, AND ASSESSED THE ATRIAL SEPTAL RIMS IN A SYSTEMATIC FASHION. THE SVC AND IVC RIMS WERE ADEQUATE, AS WELL AS THE SUPERIOR RIM TOWARD THE PULMONARY VEIN. THE AORTIC RIM WAS DEFICIENT, THE POSTERIOR RIM WAS THIN AND THE AV VALVE RIM WAS ADEQUATE. THE INTRA-PROCEDURAL TEE REVEALED NO AORTIC RIM AT 16 DEGREES. THE DEFECT WAS DYNAMIC, IN WHICH IT MEASURED 17MM IN FOUR-CHAMBER VIEW AND 13MM IN THE AORTIC VIEW. BALLOON SIZING IMAGES WERE NOT PROVIDED, HOWEVER, THE DEFECT WOULD HAVE LIKELY MEASURED BETWEEN 16-20MM (OR LARGER), DUE TO THE DEFICIENT AND THIN POSTERIOR RIM. THE ANGIOGRAMS SHOWED AN ASO PLACED WITH A SHUNT, WHICH WAS LIKELY THE ASO THAT WAS REMOVED AND REPLACED WITH AN 18MM ASO. SUBSEQUENT TO THIS LOOP, A PROPERLY DEPLOYED ASO WAS SEEN WITH THE LEFT ATRIAL (LA) DISC PROTRUDING INTO THE LA FREE WALL AT THE ROOF. AFTER RELEASE FROM, THE CABLE, THE LA DISC WAS WEDGED BETWEEN THE AORTA AND THE POSTERIOR WALL. ALL ATRIAL SEPTAL RIMS APPEARED TO HAVE BEEN SANDWICHED ADEQUATELY. THE POST-PROCEDURAL TTE SHOWED A SMALL LEFT-TO-RIGHT SHUNT IN THE FOUR-CHAMBER VIEW, ALTHOUGH, IT WAS NOT CLEARLY SEEN SO IT MAY HAVE BEEN AN ARTIFACT. THE FOLLOW-UP TTE SHOWED A PERICARDIAL EFFUSION AND TAMPONADE WITH THE ASO IN-PLACE AND THE FINAL TTE SHOWED NO PERICARDIAL EFFUSION, THE ASO HAD BEEN REMOVED AND THE ASD WAS CLOSED. ACCORDING TO AGA'S MEDICAL CONSULTANT, THIS PATIENT EXPERIENCED A DEVICE RELATED ATRIAL AND AORTIC PERFORATION DUE TO THE HIGH LOCATION OF THE DEFECT, THE DEFICIENT/ABSENT AORTIC RIM AND THE OVAL-SHAPED DEFECT.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY AGA MEDICAL EROSION BOARD CHAIRS ON (B)(6) 2011 AND DEFINITE EROSION WAS CONFIRMED.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT PERCUTANEOUS CLOSURE OF AN ATRIAL SEPTAL DEFECT (ASD). THE ASD MEASURED 15X13MM BY TEE AND A DEFICIENT ANTERIOR (AORTIC) RIM WAS NOTED. A HELEX DEVICE WAS INITIALLY ATTEMPTED, THEN WAS EXCHANGED FOR A 16MM AMPLATZER SEPTAL OCCLUDER (ASO); HOWEVER, THERE WAS FLOW SURROUNDING THE ASO. AN 18MM ASO WAS PLACED AND APPEARED WELL SEATED. THE ASO DID NOT STRADDLE OR PROTRUDE INTO THE AORTA WHEN VIEWED ON TEE POST-IMPLANT OR THE NEXT MORNING. SHE WAS DISCHARGED HOME AND AT 6:00 PM, SHE HAD CHEST PAINS AND WAS EMERGENTLY FLOWN TO THE HOSPITAL. SURGERY WAS PERFORMED AND PERFORATIONS WERE OBSERVED IN THE SUPERIOR ASPECT OF THE LEFT ATRIUM AND INTO THE AORTA.

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 3.2 INR ON THE COAGUCHEK S SYSTEM AND 2.45 INR ON A COMPARISON LAB. COUMADIN WAS NOT ADJUSTED. NO ADVERSE EVENTS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-018

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention