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

Catalog Number	ASD44A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician was implanting a 37mm gore® cardioform asd occluder to treat a thick secundum atrial septal defect (asd) static sized 18.2mm.The defect was not balloon sized.A rosen j-tipped guidewire and 14 fr sheath were used to cross the defect.The occluder was then advanced and multiple deployment attempts were made but the occluder did not successfully close the defect and a shunt remained.The 37mm device was removed and the physician selected a 44mm gore® cardioform asd occluder.Following multiple attempts of deploying and repositioning, a pericardial effusion was noted (approximately 2 hours into the procedure) and the device was removed.A pericardiocentesis was performed.One liter of fluid was tapped, and patient was watched for 20 minutes before being sent to surgery.The patient was stable before being transferred to the or.The physician was unsure of what caused the pericardial effusion but did not think it was occluder related.
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use list significant pleural or pericardial effusion requiring drainage 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 ASD 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: alexandrea holtsoi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24182790
• Report Number: 2017233-2026-07076
• Device Sequence Number: 10149565
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: (01)00733132636518(17)280602
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/10/2026

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: ASD44A
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 80 KG