MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	GSX0030A
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Elective outpatient pfo [patent foramen ovale] closure complicated by left atrial perforation and tamponade requiring emergent pericardiocentesis and pericardial drain.Sudden pericardial effusion after the insertion of the pfo device and delivery system (gore cardioform septal occluder 30mm) were placed into the body.The patient was emergently transcutaneously paced and an emergent pericardiocentesis was performed.Ricu [respiratory intensive care unit] and ct [cardiothoracic] surgery were emergently contacted for assistance.The delivery system and occluder were removed intact, occluder not deployed.Patient was ultimately admitted to the icu [intensive care unit] for close observation after determining with cardiac surgery that the patient did not need to emergently go to the or.Upon review after removal, the attending proceduralist believes the pfo occluder device was defective and thought the end was possibly more pointed than usual, the silver wire protruding from the tip of the device should not be there and likely caused the perforation.Product information: gore cardioform septal occluder 30mm.Ref (b)(4).Serial number [(b)(6)].Expiration date 7/6/2027.Manufacture date 7/7/2025.The product has been sequestered in the cath lab dirty utility room per standard workflow.And referred for further follow up and reporting.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 23061774
• Report Number: 23061774
• Device Sequence Number: 9987321
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: (01)00733132631032
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025
• Report Date (Section F): 09/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Device Lot Number: 30582890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 09/10/2025