MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TDS-09F45-80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on 21 august 2025 a 25-18mm amplatzer pfo occluder was selected for implant using a 9f amplatzer talisman delivery system to treat a patent foramen ovale (pfo).During the procedure st elevations were noted.Bubbling was observed on transesophageal echocardiogram (tee), however it was unknown whether it was due to irrigation via advancement of the delivery system or air.The procedure was aborted.The st elevations resolved on its own.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a 25-18mm amplatzer pfo occluder was selected for implant using a 9f amplatzer talisman delivery system to treat a patent foramen ovale (pfo).During the procedure st elevations were noted.Bubbling was observed on transesophageal echocardiogram (tee); however, it was unknown whether it was due to irrigation via advancement of the delivery system or air.The procedure was aborted.The st elevations resolved on its own.The patient status was stable.
Additional Manufacturer Narrative
An event of st elevation and air observed under tee was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported st elevation and air could not be conclusively determined.The reported serious injury/illness/impairment was a result of case-specific circumstances as no intervention was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TALISMAN DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 23054961
• Report Number: 2135147-2025-05205
• Device Sequence Number: 18285819
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280131(10)10707646
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: 9-TDS-09F45-80
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 10707646
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: 25-18MM AMPLATZER PFO [9-PFO-2518 LOT: 10766642].
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown