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

Catalog Number	GSX0025A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician selected a 25mm gore® cardioform septal occluder to treat a long, non-compliant patent foramen ovale.The tunnel was ballooned at the beginning of the procedure.The physician experienced difficulty crossing the defect with a glidewire.The glidewire was then switched to an amplatz guidewire, and the defect was crossed.Upon occluder deployment, it appeared the right disc was deploying in the tunnel due to the long tunnel length.The occluder was removed and the physician ballooned the tunnel a second time.The same 25mm occluder was attempted again, but the tunnel was too long to accommodate the device and it was removed.At this point the patient felt ill and then their blood pressure dropped.A pericardial effusion was noted and the patient was intubated and drained (approximately 550 ml).The patient was stable when leaving the room and was transferred to the intensive care unit with a gravity drain.
Additional Manufacturer Narrative
The gore® cardioform septal occluder instructions for use list perforation or damage of a cardiovascular structure by the device 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: 22197716
• Report Number: 2017233-2025-06305
• Device Sequence Number: 15594107
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: (01)00733132631025(17)260909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/12/2025

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: 09/09/2026
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG