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 Problem Thrombosis/Thrombus (4440)

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported to gore that a 30mm gore® cardioform septal occluder was selected to treat a patient with a patent foramen ovale (pfo).On november 24, 2022, a follow-up transesophageal echocardiogram (tee) reportedly showed thrombus formation on both left and right occluder discs.The patient was reported to be under marcumar therapy now.Another follow-up tee examination has been scheduled during the first two months in 2023.

Manufacturer Narrative

Patient weight: reported as unknown.The device remains implanted.The review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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.

Manufacturer Narrative

B5, describe event or problem: added information.H6, health effect - impact code: added code f12.H6, component code: added codes g04088, g04027.H6,type of investigation: added codes b11, b13, b20.H6, investigation conclusions: added code d12.H6, investigation findings, 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, a device evaluation could not be performed.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.According to the gore® cardioform septal 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.H6, investigation findings: replaced code c21 with code c19.H6, investigation conclusions: replaced code d16 with code d15.

Event Description

Additional information received on march 14, 2023 indicated that the patient was doing well.

• 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: 16052844
• MDR Text Key: 306187413
• Report Number: 2017233-2022-03606
• 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,Followup
• Report Date: 04/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2024
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: 57 YR
• Patient Sex: Male