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

Model Number GSX0030A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Gore® cardioform septal occluder instructions for use list significant pleural or pericardial effusion requiring drainage as a potential device- or procedure-related adverse event.

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to treat a patent foramen ovale.Prior to device introduction, the physician encountered difficulties obtaining the left atrium pressure for the procedure.The physician used a.035 j-tip wire to gain access.This wire was then exchanged for a cosida wire.The occluder was then advanced across the defect.During left disc deployment it appeared that part of the disc was in the tunnel.The device was retrieved and removed from the patient.At this point, a second guide catheter was used to gain defect access.The device was reintroduced and deployed successfully.Following device assessment, the physician noted a pericardial effusion on intra cardiac echocardiography and angiography.The patient's blood pressure began to drop and pericardiocentesis was performed.The patient stabilized and the procedure was concluded.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12745486
• MDR Text Key: 279884410
• Report Number: 2017233-2021-02509
• 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,Followup
• Report Date: 11/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• 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: 10/08/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 84 KG