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

Model Number	ASD37A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.
Event or Problem Description
It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2021 to treat an atrial septal defect.Echocardiogram on (b)(6) 2021 showed a small thrombus on the device.The patient was treated with xarelto.Follow-up echocardiogram on (b)(6) 2022 showed the thrombus present and slightly larger in size.The patient is to start on coumadin on (b)(6) 2022.
Event or Problem Description
It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2021 to treat an atrial septal defect.Echocardiogram on (b)(6) 2021 showed a small thrombus on the device.The patient was treated with xarelto.Follow-up echocardiogram on (b)(6) 2022 showed the thrombus present and slightly larger in size.The patient is to start on coumadin on (b)(6) 2022.
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.In the echo imaging provided, it appears that the device is in a stable and satisfactory position but this cannot be confirmed without fluoro imaging.The left atrial disc appears flat and well apposed to the atrial septum.The right atrial disc is also flat and well apposed to the atrial septum.The appearance of the vegetative growth on the right atrial disc is consistent with a thrombus formation.The growth is protruding into the right atrium but does not appear larger in the echo images 1 month apart.From the imaging provided, the cause of the vegetative growth cannot be determined.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13544307
• Report Number: 2017233-2022-02747
• Device Sequence Number: 5038859
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/16/2022

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: 03/15/2024
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 27 KG