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

Catalog Number	ASD44A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 44 mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring approximately 25 mm, with a deficient aortic rim and a small posterior rim.The physician attempted multiple deployments with the same device; however, after several loading and reloading cycles, the device became increasingly difficult to load.The decision was made to discontinue use of that device and proceed with a new 44 mm occluder.The replacement device was successfully implanted with assistance from the senior partner.Following implantation, the physician reported that thrombus was observed on the device during a follow-up call on friday evening.The patient subsequently developed a mild fever around tuesday evening and was evaluated at an adult emergency department before being transferred to a children¿s hospital.An echocardiogram revealed thrombus/vegetation, and antibiotics were initiated.The patient was admitted to the icu for monitoring and continued antibiotic therapy.Blood cultures showed no growth, and a repeat echocardiogram indicated resolution of the thrombus.
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: thrombosis or thromboembolic event resulting in clinical sequelae, including pharmaceutical therapy 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.
Additional Manufacturer Narrative
The patient underwent a successful explant and revision procedure on 12/19/2025 and is reported to be recovering well.

• 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23830298
• Report Number: 2017233-2025-06963
• Device Sequence Number: 5068200
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: (01)00733132636518(17)270910
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/20/2026

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: 12/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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: 11 YR
• Patient Sex: Unknown