MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® CARDIOFORM Septal Occluder; Transcatheter Septal Occluder

Catalog Number	GSX0025A
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury

• Brand Name: GORE® CARDIOFORM Septal Occluder
• Common Device Name: 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50571013
• Report Number: 2017233-2026-07978
• Device Sequence Number: 13234517
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: (01)00733132631025(17)280618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male