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

Catalog Number	ASD32A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case imaging was provided to gore for review.Fluoroscopy imaging shows a gore® cardioform asd occluder device in a locked and released position.The right atrial disc appears slightly smaller that the left atrial disc around the anterior superior rim.There is good disc spacing inferiorly.The locking loop is present around the right atrial eyelet.Echocardiographic imaging (post-surgery) shows a clear shunt around the device and the right disc has prolapsed into the fossa ovalis.
Event or Problem Description
Additional information received: transesophageal echocardiography was reviewed following the surgery and it appeared that part of the device shifted into the left atrium and a 3-4mm color jet was noted.The physician decided to leave the device implanted and continue to monitor the patient.
Additional Manufacturer Narrative
The gore® cardioform asd 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.
Event or Problem Description
It was reported the physician selected a 32mm gore® cardioform asd occluder to treat an atrial septal defect.While deploying the occluder, the physician noted a pericardial effusion.The occluder was locked and released.Echocardiography showed a large pericardial effusion and pericardiocentesis was performed.A drain was placed and blood was removed from pericardial sac, but bleeding continued.Following consultation with cardiothoracic surgery, a decision was made to perform a pericardial window.A pericardial window was performed, but the bleeding could not be controlled and the procedure was converted to open heart surgery.The patient was placed on bypass, and surgery was performed.Injury to the left atrium was noted and repaired.The patient was doing well following the procedure.The physician believes the device perforated the wall of the left atrium by the right pulmonary vein, adjacent to the left atrial appendage.2600-a:-supplemental (physician believes the damage to the left atrial wall was device related).

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23878310
• Report Number: 2017233-2025-06995
• Device Sequence Number: 9650265
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: (01)00733132636495(17)280809
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/22/2026

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: ASD32A
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Race: Asian