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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Fever (1858); Thrombosis/Thrombus (4440)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Literature article attached: percutaneous repair of a sinotubular junction aortic pseudoaneurysm with an asd occluder: a case report as reported in a research article, a septal occluder was used off-label to close a mycotic pseudoaneurysm with thrombus and residual shunt within the pseudoaneurysm being found 48 hours after implant.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

Event Description

The article, "percutaneous repair of a sinotubular junction aortic pseudoaneurysm with an asd occluder: a case report" was reviewed.The article presented a case study of a 69-year-old male patient with aortic pseudoaneurysm, past medical history of hypertension, dyslipidemia, prior coronary artery bypass graft, and pericardial drainage for purulent pericarditis.It was reported that on an unknown date, an 8mm amplatzer septal occluder was chosen for an off label procedure for percutaneous closure of a mycotic pseudoaneurysm.A transthoracic echocardiogram following procedure demonstrated the occluder was well seated.It was then reported on a follow up transesophageal echocardiogram (tee) 48-hours post procedure confirmed appropriate position of the device with thrombus and residual shunt within the pseudoaneurysm.Repeat tee 15 days post-procedure showed decrease in pseudoaneurysm with thrombus and again ongoing residual shunt.Three months post-procedure, the patient presented to the hospital with fever and malaise with increase in pseudoaneurysm in the context of chronic infective aortitis and residual flow.The patient was planned on continued lifelong antibiotic therapy for presumptive infective aortitis.The article concluded that percutaneous closure of a mycotic pseudoaneurysm with an asd occluder device can be a safe and efficacious treatment option, especially in patients with prohibitive surgical risk.[the primary and corresponding author was benjamin hibbert, department of cardiovascular medicine, mayo clinic, rochester minnesota, with corresponding email: hibbert.Benjamin@mayo.Edu].

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18364685
• MDR Text Key: 330998851
• Report Number: 2135147-2023-05600
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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 Age: 69 YR
• Patient Sex: Male