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

Model Number GSX0025A

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/14/2022

Event Type  Injury  

Event Description

It was reported to gore a 25mm gore® cardioform septal occluder was implanted on (b)(6) 2021 to treat a patent foramen ovale.During a one year follow-up echocardiogram on (b)(6) 2022, thrombus was noted on the left side.The patient was started on eliquis and will be scheduled for transesophageal echocardiogram.It was reported that no thrombus were noted on the 1 month echocardiogram post implant.There is no reported history of clotting disorder.

Manufacturer Narrative

Patient weight was requested, but was not available.Imaging evaluation: the follow up imaging at one year showed a growth in the left atrium and on the tip of the left atrial eyelet.In the echo imaging provided, it appears that the device is in a stable and satisfactory position but this cannot be confirmed without fluoro imaging.The left atrial disc appears flat and well apposed to the atrial septum.The right atrial disc is also flat and well apposed to the atrial septum.The appearance of the vegetative growth on the left atrial eyelet and is consistent with a thrombus formation.The growth is protruding into the left atrium and appears to attach to the wall of the left atrium but does not appear larger in the echo images 1 week apart.From the imaging provided, the cause of the vegetative growth cannot be determined but it is suspected that it came from the tunnel track during implantation.This is suspected due to the thrombus only forming on the tip of the left atrial eyelet and not on the fabric.It is suspected that there was thrombus in the tunnel when crossing with the catheter and when advancing the left atrial disc, the thrombus was then pushed onto the left atrial eyelet.This cannot be confirmed without additional imaging.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.

Manufacturer Narrative

Additional information received: it was reported that on (b)(6) 2022, the patient was taken to surgery for a suspected thrombus.An atrial myxoma was found, no thrombus.The atrial myxoma tumor and the device were removed and the defect was closed.The patient was reported to be doing well.It was reported the physician confirmed it was an atrial myxoma and it was not present at time of device implant.The physician indicated the atrial myxoma is not device related.Medwatch report 2017233-2022-02857 is being retracted.

• 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: 14083954
• MDR Text Key: 289067369
• Report Number: 2017233-2022-02857
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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: Female