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

Model Number GSX0030A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 12/09/2021

Event Type  Injury  

Event Description

It was reported the physician was implanting a 30mm gore® cardioform septal occluder.After lock release, while still attached to the retrieval cord, it was noted that the left disc prolapsed through the defect.While removing the device with the retrieval cord, the cord slipped through the red clamp on the handle and the device embolized to the pulmonary artery.The device was easily removed with a loop snare.The patient was doing well following the procedure.

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.

• 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: 13168143
• MDR Text Key: 283513326
• Report Number: 2017233-2022-02653
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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
• Report Date: 01/05/2022

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: 08/05/2022
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/05/2022
• Date Device Manufactured: 08/05/2020
• 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): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 108 KG