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

Catalog Number GSX0025

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported, the physician implanted a 25mm gore® cardioform septal occluder on an unknown date in 2020, to close a patent foramen ovale.A thrombus was noted on the left and right disc of the device.The defect was surgically closed, and the device was removed, sometime in (b)(6) 2022.The surgeon noted that the device had a small part that was not epithelialized."on the left side of the device, the majority of the device was epithelialized, except for an exposed metal ring at the very center of the device." the patient¿s hypercoagulable workups had been unremarkable.The thought is that the patient has an underlying hypercoagulable state that the hospital has no test for.The patient was doing well following the surgery.

Manufacturer Narrative

No serial # or other details could be obtained from the hospital 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: thrombosis or thromboembolic event resulting in clinical sequelae.

Event Description

It was reported, the physician implanted a 25mm gore® cardioform septal occluder on an unknown date in 2020, to close a patent foramen ovale.A thrombus was noted on the left and right disc of the device.The defect was surgically closed, and the device was removed on (b)(6) 2022.The surgeon noted that the device had a small part that was not endothelialized."on the left side of the device, the majority of the device was epithelialized, except for an exposed metal ring at the very center of the device." the patient¿s hypercoagulable workups had been unremarkable.The thought is that the patient has an underlying hypercoagulable state that the hospital has no test for.The patient was doing well following the surgery.

• 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14240609
• MDR Text Key: 290453449
• Report Number: 2017233-2022-02889
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSX0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female