MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information comes from the abstract titled "a case of infective endocarditis presented 2 years after transcatheter closure of atrial septal defect (asd) which was difficult to treat." when the patient was (b)(6), an amplatzer septal occluder (aso) of an unknown size was implanted in an atrial septal defect (asd) that measured 12 mm.At (b)(6) the patient continuously vomited for two days and was admitted to a hospital.The following symptoms were observed: hyperemia of ocular mucosa, redness of lip, cervical rigidity, intensive inflammatory response, elevation in the number of cerebrospinal fluid cell and hypoglycorrhachia.Bacterial meningitis was suspected and antibiotics were administered.That night, cardiac insufficiency was present.As the patient's condition met the main symptoms of kawasaki disease, immunoglobulin therapy was started.The next day the patient was still in the hospital, acute encephalopathy developed.Steroid pulse therapy was conducted.Although the patient's fever decreased, (b)(6) was detected by blood culture.Janeway lesion and roth's spots were observed as well.The patient was diagnosed as infective endocarditis which resulted in kawasaki disease and acute encephalopathy.No vegetation was observed.The patient was doing well after the steroid pulse therapy.On the 22nd day of admission, a mobility extraneous matter measuring 12 x 4 mm in size was adhered to the aso left atrial disc, the patient was referred to the reporting hospital.A surgical intervention was suggested by the physician but the patient rejected.The physician assumed that mobility extraneous matter was likely to be vegetation caused by infective endocarditis, therefore antibiotics were changed.In order to prevent thrombus formation, anticoagulation therapy was started.The vegetation gradually shrank.On the ninth day after being admitted to the second hospital, a complication of infective cerebral aneurysm was suspected through magnetic resonance angiography (mra).Warfarin was discontinued but heparin was continued.The vegetation was repeatedly growing and shrinking, and mild cerebral infarction developed.Meanwhile, cerebral aneurysm had not become worsen.Administration of antibiotic was reported to be continued for 6 weeks.When warfarin was restarted to be administered, vegetation disappeared.The patient was discharge after 61 days in the second hospital.The risk of infective endocarditis is generally considered not to be higher in cases where the patient underwent transcatheter closure of asd more than 6 months before.However, the author stated that the physician should pay careful attention to development of infective endocarditis long term after aso deployment.Doi: iii-p38-04.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6875214
• MDR Text Key: 86570532
• Report Number: 2135147-2017-00113
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR