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

Catalog Number ASD48E

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

H3, code "other": the explanted device was discarded at the facility.Therefore, an evaluation of the explant could not be performed.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 to gore that on (b)(6) 2023 a 48 mm gore® cardioform asd occluder was selected to percutaneously treat a multifenestrated atrial septal defect (asd).Using balloon sizing, the defect measured 31 mm under transesophageal echocardiography and 34 mm under angiography imaging.The device was implanted with a good outcome closing all septal fenestrations.On (b)(6) 2023, the patient was discharged under double antiplatelet therapy.After the first unremarkable follow-up visit on (b)(6) 2023, transthoracic echocardiography on (b)(6) 2023, identified a significant thrombus formation on the right disc and it was decided to remove the device.On october 6, 2023, the device was explanted and the thrombus formation was confirmed located on the right disc and partially inside the device.Subsequently, the defect was closed with a patch and there reportedly were no clinical sequelae.According to the physician, it was only after device removal the patient reported she had never stopped taking the contraceptive pill prior and post device implant.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, investigation findings: code 19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.Imaging evaluation summary: a transthoracic echocardiography image and two intraprocedural images taken during the explant procedure were returned to gore and an imaging evaluation was performed.The transthoracic echocardiography image revealed an organized echogenic structure on the gore cardioform asd occluder.The echogenic structure was attached to the anterior inferior portion of the right atrial disc and resides above the atrioventricular valve junction.The mobile structure estimated to be around 15 mm long with a band like appearance that protrudes into the right atrium.Surgical removal of the gore cardioform asd occluder was performed and intraprocedural images confirmed growth of the thrombotic structure on the occluder.This complaint was initiated based on information received from the field.The available information reported does not reasonably suggest a potential malfunction has occurred.Thrombosis represents a known complication or adverse event that can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.No further information was provided to gore for this patient.Based on the incident description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.According to the gore® cardioform asd occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.

• Brand Name: GORE® CARDIOFORM ASD 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: 18282233
• MDR Text Key: 329936587
• Report Number: 2017233-2023-04454
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 04/05/2024

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: ASD48E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female