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

Model Number GSX0025A

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Embolism/Embolus (4438)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use state in the section ¿potential device, or procedure related adverse events¿ adverse events associated with the use of the occluder may include, but are not limited to: device embolization.

Event Description

It was reported on (b)(6) 2022, the physician was implanting a 25mm gore® cardioform septal occluder to close a large, long tunnel patent foramen ovale (pfo).During the implant, the device initially embolized to the left ventricle.The patient was taken to the or for surgical closure of the pfo and removal of the device.In the or an echo was repeated, and this showed that the device had migrated to the descending aorta, where it was removed in a transcatheter procedure from the left femoral artery.The patient had the pfo surgically closed and was doing well following the procedure.

• 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: 13981180
• MDR Text Key: 288875779
• Report Number: 2017233-2022-02840
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022

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 Expiration Date: 10/20/2023
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/01/2022
• Date Device Manufactured: 10/21/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White