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

Model Number	GSX0020A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional 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: significant pleural or pericardial effusion requiring drainage.
Event or Problem Description
It was reported the physician implanted a 20mm gore® cardioform septal occluder.Two hours following the procedure a pericardial effusion was noted and the patient was treated with a pericardiocentesis.The device remains implanted, and the patient was doing well following the procedure.The physician was unsure if it was the device or guide wire that caused the issue.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12433516
• Report Number: 2017233-2021-02338
• Device Sequence Number: 19697348
• Product Code: MLV
• UDI-Device Identifier: 00733132631018
• UDI-Public: 00733132631018
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: GSX0020A
• Device Catalogue Number: GSX0020A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 58