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

Catalog Number	GSX0030A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: no patient weight available.The gore® cardioform septal occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: significant pleural or pericardial effusion requiring drainage.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 the physician was implanting a 30mm gore® cardioform septal occluder to close an aneurysmal patent foramen ovale (pfo).The pfo was crossed with a.035 guidewire and mpa catheter.Using intracardiac echocardiography, multiple attempts were made to get the wire into the left or right upper pulmonary vein.A new amplatz wire was inserted into the left atrial appendage and the catheter was removed.The 30mm device was inserted over the wire across the pfo.The left disc was deployed but took on an odd shape of possible being deployed in the tunnel.The echo images were not showing the device well as the device was moved forward.One more attempt to form the left disc was happening when the blood pressure was noted to be dropping.An effusion was noted in the roof of the left atrium, so the delivery system was removed from the patient.A pericardiocentesis was performed but due to reoccurring bleeding the patient was taken to the or and a pericardial window was performed to address the effusion.The patient was stable following the procedure.

• 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24177066
• Report Number: 2017233-2026-07074
• Device Sequence Number: 21376890
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: (01)00733132631032(17)271021
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/26/2026

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: 01/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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: 27 YR
• Patient Sex: Female