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

Catalog Number GSXE0030

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

Patient Problems Fever (1858); Thrombosis/Thrombus (4440)

Event Date 04/06/2024

Event Type  Injury  

Event Description

It was reported to gore that on april 5, 2024, a 30 mm gore® cardioform septal occluder was selected to treat a patent foramen ovale with a short tunnel but a mobile septum.As post-operatively on (b)(6) 2024, the patient was diagnosed with a temperature of 39 degrees celsius, a c reactive protein value of 35 mg/l and an elevated leucocyte count of 18,000 cells, antibiotic therapy was started.However, blood cultures from the patient showed no pathogenic agent.On (b)(6) 2024, follow-up medical imaging showed what the physician believed could be a thrombus but visualization was unclear.Therefore, the physician decided to initiate antiplatelet and anticoagulant medication as prophylactic treatment.On (b)(6) 2024, follow-up fluoroscopy imaging verified the wire frame was not broken and transthoracic echocardiogram (tte) imaging performed on (b)(6) 2024 did also not provide a clearer understanding.However, transesophageal echocardiography (toe) and 3d echocardiography conducted on (b)(6) 2024 were able to confirm a device thrombus, likely already reduced due to medication treatment.The patient was reported to have been well and that the medication regimen would continue for another 4 weeks.

Manufacturer Narrative

H6, type of investigation: code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The device remains implanted.Therefore, an evaluation of the device cannot be performed.However, medical images of the implanted device were returned to gore and are currently being investigated.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
• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19211391
• MDR Text Key: 341357664
• Report Number: 2017233-2024-04879
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 09/24/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 73 KG