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

Device Problem Biocompatibility (2886)

Patient Problems Endocarditis (1834); Fever (1858); Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

Events of vegetation and endocarditis were reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that the patient had a history of atopic dermatitis.

Event Description

Complaint information from literature of the japanese society of pediatric cardiology and cardiac surgery (id# (b)(6)).On an unknown date, an amplatzer septal occluder (aso / unknown size) was implanted in a (b)(6) male patient.Six months later, the patient presented with fever and pain of the distal extremities.Infectious endocarditis was suspected and echocardiogram revealed vegetation on the aso and anterior cusp of the mitral valve.Mitral valve regurgitation was also observed due to the perforation of the anterior leaflet.Blood culture detected (b)(6)mri revealed multiple cerebral embolisms.The next day, an emergency procedure was performed to remove the vegetation and aso as well surgical closure of the atrial septal defect, and mitral valve repair.The patient was reported in good condition and discharged after antibiotic therapy for five weeks.Recurrence of the infection was not observed.Per physician's opinion, the patient's comorbidity (atopic dermatitis) was considered an infectious route.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8073922
• MDR Text Key: 127249762
• Report Number: 2135147-2018-00213
• 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: Physician
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/15/2018
• 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: 21 YR