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

Catalog Number	GSX0025A
Medical Device Problem Code	Prophylactic removal due to corrective action (4077)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform septal occluder instructions for use warns; adverse events associated with the use of the occluder may include, but are not limited to: allergic reaction.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.
Event or Problem Description
It was reported to gore that during a lab workshop, the physician shared a prior clinical experience involving a patient with a suspected nickel allergy.The patient underwent a successful and uneventful pfo closure procedure using a gore® cardioform septal occluder (gso) on (b)(6) 2019, to treat hypoxemia with activity.Approximately two weeks post-implant, the patient presented with chest pain and shortness of breath.On (b)(6) 2019, she was admitted to the emergency room with a pericardial effusion and was treated with prednisone.She returned on (b)(6) 2019, with recurrent shortness of breath, and the physician noted that the pericardial effusion was not large enough to cause tamponade.Symptoms again improved with prednisone.On (b)(6) 2019, the patient was hospitalized again with a pericardial effusion and was referred to the allergy department, where nickel allergy was confirmed via skin testing.Based on the suspected allergic reaction, the decision was made to explant the device.On (b)(6) 2019, the patient underwent robotic-assisted surgical removal of the gso and a linq heart failure monitor.The procedure was completed without complications.Following device removal, the patient¿s symptoms resolved, and no residual shunt was observed.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release specifications.

• 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23069609
• Report Number: 2017233-2025-06613
• Device Sequence Number: 17339859
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: (01)00733132631025(17)210213
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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 Expiration Date: 02/13/2021
• Device Catalogue Number: GSX0025A
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 92 KG