MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II; TRANSCATHETER SEPTAL OCCLUDER

Model Number CVD0095

Device Problem Biocompatibility (2886)

Patient Problems Endocarditis (1834); Tachycardia (2095); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had the amplatzer duct occluder explanted after approximately two weeks due to endocarditis.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported in an article titled, "infective endocarditis developing early after percutaneous closure of a patent ductus arteriosus in a child using the amplatzer duct occluder ii" that a patient underwent patent ductus arteriosus closure using the amplatzer duct occluder ii device and was discharged a day after the procedure.After 1 week, she presented with tachypnoea, fatigue, and a fever.Blood cultures were performed, the patient became hospitalized and was placed on empirical antibiotherapy.The initial echocardiogram (ecg) revealed the device was in an appropriate position.Consecutive blood cultures yielded staphylococcus aureus in all seven blood cultures started during the first 3 days.The device was explanted, the fever abated and the patient's general condition improved immediately after the operation.The final ecg revealed no residual shunt and she was reported to be discharged 4 weeks after the cardiac procedure.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9986428
• MDR Text Key: 188561676
• Report Number: 2135147-2020-00174
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• 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: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0095
• Device Catalogue Number: CVD0095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 10 MO