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

Model Number	9-PFO-2518
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of air/gas in device was reported with air embolism, ekg changes, bradycardia, and myocardial infarction.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported air/gas in device could not be determined.The reported air embolism, ekg changes, bradycardia, and myocardial infarction is likely cascading effects from the event.An unexpected medical intervention was a result of case-specific circumstances, as medication was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using an 8f amplatzer talisman delivery system.The delivery system was opened and prepared in a sterile manner, ensuring all air was removed from the sheath and dilator.The occluder device was prepared under water by the physician while the scrub technician flushed normal saline through the side port of the touey.During the initial preparation, a bubble was noted at the proximal end of the device, prompting the physician to remove and reload the device, after which no air was observed.A non-abbott guidewire was then placed through the multi-purpose (mp) catheter positioned across the pfo, followed by removal of the mp catheter and sheath.The 8f amplatzer talisman delivery system was advanced across the 30-25mm amplatzer talisman pfo occluder and positioned at the ostium of the left upper pulmonary vein, and a wet-to-wet connection was established with the device loader.The device was advanced without fluoroscopy until the demarcation line reached the touey, and under fluoroscopic and ice guidance, the left atrial disc was deployed without visible air.At the time of deployment, intravenous medications were being administered, and a significant rush of bubbles was noted on ultrasound.The patient became restless, exhibited movement, and developed ectopy followed by sudden st elevation in posterior leads, raising suspicion of air embolism.The physician proceeded to deploy the right atrial disc, and the device appeared well-positioned with no flow limitations.The patient subsequently developed bradycardia, and the physician diagnosed stemi; atropine was administered.A left heart catheterization was performed, which revealed no blockages or air emboli.The patient was monitored for an additional 10 minutes, and st segments returned to baseline within 20 minutes.The procedure was completed successfully with the device implanted, and the physician expressed no further concern regarding cardiac damage.The patient was under conscious sedation, no continuous flush was attached, and there were no issues with guidewire or dilator removal.No leak was noted in the delivery system, and no air was observed in the device during preparation or deployment.There was no allegation of device malfunction, the user believes the event likely occurred due to the air that was not appreciated by the team during the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Common Device Name: 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: 24169050
• Report Number: 2135147-2026-00414
• Device Sequence Number: 13043794
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)280630(10)10945687
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 10945687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8F AMPLATZER TALISMAN DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male