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

Catalog Number GSXE0025

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/30/2021

Event Type  Injury  

Event Description

It was reported to gore that a 25mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo).The device was implanted without issue.Reportedly, patient history states a stroke in (b)(6) 2021 and multiple differential diagnoses were subsequently performed including a bubble study confirming a pfo.Follow-up examination revealed a thrombus on the right disk.Being on antiplatelet and anti-inflammatory medication post-procedure, the patient has additionally started anticoagulant medication to resolve the thrombus.It was reported that one week into the anticoagulant treatment the thrombus was still present but had become smaller.

Manufacturer Narrative

H6, health effect - impact code: added imdrf code f12.H6, component code: added imdrf codes g04088, g04027.H6, type of investigation: added imdrf codes b11, b13, b20.H6, investigation conclusions: added imdrf code d12.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, health effect - clinical code: replaced fda code 4440 with imdrf code e0514.H6, health effect - impact code: replaced fda code 4644 with imdrf code f2303.H6, medical device problem code: replaced fda code 2993 with imdrf code a24.H6, type of investigation: replaced fda code 3331 with imdrf code b14.H6, investigation findings: replaced fda code 3233 with imdrf code c19.H6, investigation conclusions: replaced fda code 11 with imdrf code d15.

• 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: 13502258
• MDR Text Key: 286124681
• Report Number: 2017233-2022-02730
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 69 KG