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

Catalog Number	GSX0025A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a percutaneous procedure to treat a patent foramen ovale, the initially selected septal occluder could not be positioned and deployed as intended and was removed.A second device of the same size was subsequently placed successfully.Following the procedure, the patient developed a pericardial effusion that required pericardiocentesis.An analysis of production and manufacturing records for the involved lot was performed and did not identify any nonconformances or manufacturing issues.Based on the available information, no definitive manufacturing defect was identified.The adverse event occurred in the context of attempted device deployment during the procedure.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: 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 that a 25 mm gore® cardioform septal occluder was selected to treat a patent foreman ovale (pfo).Reportedly, the pfo was crossed without issue and was initially positioned appropriately; the defect was not balloon sized.During deployment of the left atrial disc, the disc appeared to deploy within the pfo tunnel.The physician retracted the disc into the delivery system, advanced the system, and attempted redeployment, but the disc appeared "squished".The entire delivery system was removed, and a new device of the same size was successfully deployed without issue.Following device implant, the patient experienced a reaction to a protamine test dose and had also developed a pericardial effusion requiring pericardiocentesis, which was assessed by the physician as being related to the first device attempted.The patient ultimately tolerated the procedure and the device remains implanted.

• 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: 25047508
• Report Number: 2017233-2026-07446
• Device Sequence Number: 18587200
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: (01)00733132631025(17)271101
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 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: 04/15/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2025
• 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: Required Intervention
• Patient Sex: Unknown