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

Model Number GSX0025A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 04/25/2021

Event Type  Injury  

Manufacturer Narrative

No patient weight was available.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, the physician implanted a 25mm gore® cardioform septal occluder on (b)(6) 2020.The device was implanted with no issues.On (b)(6) 2021 the patient was feeling pain in the abdomen and went to the hospital.A ct revealed the device had embolized to the distal thoracic aorta, proximal to the ciliac artery.A snare was attempted to remove the device, but it was adhered to the wall of the artery.A terumo aortic endograft was used to pin the occluder against the wall of the artery.The patient was doing well following the procedure.The patient only had a one-month follow-up, showing the device in place.

Manufacturer Narrative

B5: updated description with new information.

Event Description

It was reported, the physician implanted a 25mm gore® cardioform septal occluder on (b)(6) 2020.The device was implanted with no issues.On (b)(6) 2021 the patient was feeling pain in the abdomen and went to the hospital.A ct revealed the device had embolized to the distal thoracic aorta, proximal to the ciliac artery.A snare was attempted to remove the device, but it was adhered to the wall of the artery.A terumo aortic endograft was used to pin the occluder against the wall of the artery.The patient was doing well following the procedure.After the original implant, the patient was lost to follow-up, so no follow-up imaging was performed.The last images showed the device in place at discharge.

• 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: 11852381
• MDR Text Key: 255932469
• Report Number: 2017233-2021-02019
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR