MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number 9-ATV08F45/80

Device Problem Biocompatibility (2886)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

An event of atrial fibrillation (af) during the procedure in a patient with no known history of af was reported.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

Reference manufacturing report number: 2135147-2020-00120.On (b)(6) 2019, a 35mm amplatzer pfo occluder was implanted using an.The patient has a history of stroke, but did not have any known history of atrial fibrillation.During the procedure while crossing the septum, the patient went into atrial fibrillation.The patient was initially schedules for dc cardioversion on (b)(6) 2019, but converted spontaneously to normal sinus rhythm on his own.On (b)(6) 2020, an injectable loop recorder was implanted.

Event Description

Additional information received indicates that on (b)(6) 2021, paroxysmal atrial fibrillation was confirmed.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9851072
• MDR Text Key: 184069694
• Report Number: 2135147-2020-00121
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K190581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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
• Device Model Number: 9-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER GUIDEWIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR