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 Problems Atrial Fibrillation (1729); Fever (1858)

Event Date 05/20/2023

Event Type  Injury  

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was successfully implanted on (b)(6) 2023 to treat a patent foramen ovale.Echocardiogram and fluoroscopy imaging were fine post implant.Estimated date of fever onset was three days post implant, (b)(6) 2023.On (b)(6) 2023 the patient presented to a different hospital with renal failure, and a "full device".Imaging showed the device was stable and the patient was discharged back to the implanting facility.The implanting physician mentioned that an antibiotic reaction may have caused the issue, however, he is still investigating with a pet scan and more imaging.The fever has resolved and the patient is doing well.The physician reported no thrombus at this time.Additional information received may 28, 2023.Per progress note dated (b)(6) 2023 impression: febrile illness post elective pfo closure, aki (acute kidney injury), ? ain ( allergic interstitial nephritis) due to flucloxacillin, rash ? antibiotic related.Second progress note signed (b)(6) 2023: new atrial fibrillation captured.Patient is hospitalized and requiring anticoagulation and continued antiplatelet treatment.Continue metoprolol for rate control atrial fibrillation and evaluation by cardiologist for arrhythmia treatment plan.Update received on june 1, 2023 reporting that once the antibiotics were stopped the patient improved and was discharged.

Manufacturer Narrative

A review of the manufacturing and sterilization records for the device verified that the lot met all pre-release specifications.The device remains implanted.Imaging evaluation results: in echo image one you can see that there is a small right disc expansion.There is not any evidence of thrombus.In echo image 2, the device appears to be in a stable position with the appropriate discs on the correct side.Without fluoroscopy imaging, this cannot be confirmed.It is suspected by the physician that the fever was induced by an antibiotic allergic reaction.The fever resolved and the patient is doing well.The patient also developed atrial fibrillation on (b)(6) 2023.The physician placed the patient on antiplatelet therapy and will continue to monitor the patient.The cause for the fever as well as the arrhythmia cannot be determined.The gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: fever, new arrhythmia requiring treatment.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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17133885
• MDR Text Key: 317213790
• Report Number: 2017233-2023-04020
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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
• Date Manufacturer Received: 05/28/2023
• Date Device Manufactured: 07/25/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male