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

Catalog Number GSXE0020B

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device information was not provided; therefore, an investigation is unable to be performed.The gore® cardioform septal occluder instructions for use note that this device is not recommended for, and has not been studied in the treatment of fenestrated fontan.

Event Description

It was reported a patient underwent a fenestrated fontan procedure in 2011.In 2019, the fenestration was closed with a 20mm gore® septal occluder (gso).In (b)(6) 2022, the patient presented with reduced exercise tolerance and cardiac mri showed narrowing/stenosis of the fontan tunnel.An angiogram identified that the gso was deformed and partially occluding the lumen of the fontan conduit.Correspondence with the implanting facility confirmed the device was normally configured at the time of implant.On (b)(6) 2022, a reintervention was performed utilizing a stent to reopen the fontan conduit.The gso remains implanted and the patient was doing well following the procedure.The physician noted concern with potential frame fractures of the gso device.

• 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: 13698283
• MDR Text Key: 290548925
• Report Number: 2017233-2022-02793
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSXE0020B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• 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: 15 YR
• Patient Sex: Male