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

Catalog Number GSXE0030B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

Echocardiographic images were returned for evaluation.In the imaging provided, the reported growth can be visualized.It appears to be on the right atrial disc but that cannot be confirmed.It also cannot be confirmed if the growth is on the disc or contained in the fabric, which would be consistent with right atrial disc expansion.The possibility of a myxoma cannot be ruled out even though they are typically found in the left atrium.Without x-ray imaging it cannot be determined if the device is in a proper locked position with the appropriate discs on the correct sides.The gore® cardioform septal occluder instructions for use list thrombosis as a potential device or 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 Description

It was reported the physician implanted a 30mm gore® cardioform septal occluder to treat a patent foramen ovale on (b)(6) 2023.Approximately three weeks following implant, patient examination showed a mobile mass attached to the right atrial disc of 1.2 cm length and 8 mm width, consistent with either mobile thrombus or vegetation material.There was no evidence of valvular endocarditis.There was an unusually widened tissue filled space between the right and left sided discs of the occluder.An mri was performed and the results were normal.The patient is currently on clopidigrel only as they are allergic to aspirin.Additionally, the patient has a slightly elevated white cell count and has been prescribed xaralto for thrombus.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: 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: 18219056
• MDR Text Key: 329146579
• Report Number: 2017233-2023-04432
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: GSXE0030B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2023
• Initial Date FDA Received: 11/28/2023
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female