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

Model Number	ASD48A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/09/2021
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 the physician implanted a 48mm gore® cardioform asd occluder on (b)(6) 2021.At a follow-up appointment on (b)(6) 2021, a thrombus was noted within the right disc.The patient was treated with xarelto and will have follow-up imaging.
Additional Manufacturer Narrative
The imaging investigation stated the following: it was reported that a physician implanted a gore cardioform asd occluder.Approximately a month later during follow up echocardiography a thrombus was noted on the right atrial disc.Limited imaging was provided for this review.There does appear to be an echogenic mass associated with the right atrial disc.This appearance is consistent with that of thrombus.With the limited imaging, it is difficult to assess if the device is implanted properly.Also, it is difficult to ascertain the cause of the thrombus.

• 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
• MDR Report Key: 12413808
• Report Number: 2017233-2021-02328
• Device Sequence Number: 19928031
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Weight: 21