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

Model Number	ASD48A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.
Event or Problem Description
It was reported the physician selected a 48mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 30-32mm.Following deployment, both fluoroscopic and transesophageal (tee) imaging showed equal deployment of the left and right discs on their respective sides of the septum.The device was then locked, and after further imaging review showed the device well positioned, the retrieval cord was removed.After removal of the retrieval cord there was some question about the appearance of one of the left petals on tee, so the physician decided to further interrogate using intracardiac echocardiography (ice).Before the ice catheter could be advanced into place, the device prolapsed completely into the right atrium.The physician attempted to remove the device with a snare; however, the attempt was unsuccessful as the device had shifted into the tricuspid valve and was sitting in both the right atrium and right ventricle.The physician felt that device closure was not going to be possible due to the patient's anatomy, so a surgeon was alerted and the decision was made to take the patient to the operating room for device removal and surgical defect repair.The physician later reported that the device was removed safely with no damage to the tricuspid valve and the atrial septal defect was surgically closed with no adverse effects.

• Brand Name: GORE® CARDIOFORM ASD 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12991088
• Report Number: 2017233-2021-02609
• Device Sequence Number: 17461630
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: ASD48A
• Device Catalogue Number: ASD48A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/13/2021
• Date Device Manufactured: 01/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 70 KG