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

Model Number GSX0030A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Pericardial Effusion (3271)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: significant pleural or pericardial effusion requiring drainage, device embolization.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.The device was deployed and locked and the retrieval cord was pulled back.At this time it was reported the physician pulled on the handle causing the device to pull back and the right eyelet unlocked.The physician attempted to snare the device into a 14fr sheath, however, the device embolized to the pulmonary artery.A second attempt to snare the device was unsuccessful as the device slipped off again and embolized a second time to the pulmonary artery.At this time a pericardial effusion was noted and the patient was taken to the operating room for retrieval of the device.

Manufacturer Narrative

H6: updated investigation findings and conclusions codes.

• 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
• MDR Report Key: 12143796
• MDR Text Key: 260757094
• Report Number: 2017233-2021-02154
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 91