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

Catalog Number	GSX0030A
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician implanted a 30mm gore® cardioform septal occluder to close a patent foramen ovale on (b)(6) 2025.On (b)(6) 2025, the patient presented at a hospital with chest pain and a transthoracic echocardiogram was performed, noting thrombus on the right atrial disc.Transesophageal echocardiography was performed at a different hospital (implant site) on (b)(6) 2025.Imaging demonstrated thrombus on the right atrial disc.The patient will be treated with anticoagulation medication.
Additional Manufacturer Narrative
Echocardiographic imaging was provided for evaluation.A gore® cardioform septal occluder can be visualized.The discs appear well apposed to the appropriate sides, however without additional imaging this cannot be confirmed.There is a large mass noted on the right atrial disc.It is unable to be determined if mass is contained within the right atrial disc or on the outside of the disc.It is important to note that with the limited imaging provided, the mass that is shown cannot be confirmed as thrombus.The gore® cardioform septal occluder instructions for use list thrombosis resulting in clinical sequalae, including pharmaceutical therapy as a potential device and procedure related adverse event.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22963770
• Report Number: 2017233-2025-06567
• Device Sequence Number: 15740926
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: (01)00733132631032(17)270428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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 Catalogue Number: GSX0030A
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 62 KG