MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Fever (1858); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "infective endocarditis with giant mobile vegetation that developed 3 years after amplatzer septal occluder implant", was reviewed.The research article presents a case study on a (b)(6)-year-old male who underwent catheterized atrial septal defect closure at the age of (b)(6) using an amplatzer septal occluder.After the procedure, antiplatelet therapy with biaspyrin was continued for 6 months.Three years post-procedure, the patient experienced infective endocarditis with giant mobile vegetations.The patient had fever and malaise for 2 weeks, and (b)(6) was detected in blood culture.Computed tomography showed a low density area around the device, and transesophageal echo showed a huge vegetation with mobility on the left atrioventricular side, and the patient underwent a semi-emergency operation.On the right atrium side, a huge vegetation was found around the device.An incision was made in the atrial septum and the device was removed along with the vegetation.Huge vegetation were also found on the lower right edge of the device on the left tuft side, and all of these were also resected and cleared.Since both the right atrium and the left atrium had huge defects, they were reconstructed using bovine pericardium.After the operation, the patient was treated with antibiotics for 6 weeks and was discharged without complications.Antiplatelet drug administration 6 months after amplatzer and prevention of infective endocarditis are based on data from animal experiments, and it is said that the device was completely covered with endocardium in 3 months.However, in this intraoperative finding, the device was not completely covered by the intima, and a huge vegetation was generated around that site.The article concluded that infective endocarditis of amplatzer in the distant period is rare, but there are some reports, and some findings are not covered by pseudoendocardium.In the future, evaluation of pseudonormalization after insertion of amplatzer, accumulation of long-term data, and guidelines based on them will be required.

Manufacturer Narrative

As reported in a research article, a patient underwent atrial septal defect closure with an amplatzer septal occluder; 3 years later an event of infective endocarditis, mobile vegetations, and device explant was reported a more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11542919
• MDR Text Key: 241758545
• Report Number: 2135147-2021-00103
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR