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

Model Number ASD32A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported, the physician implanted a 32mm gore® cardioform asd occluder on (b)(6) 2021, to close an atrial septal defect (asd).The device was implanted with no issues.At a two-week follow-up echocardiography, the device was in good position with no thrombus.On (b)(6) 2021 a thrombus was noted on the right disc.The device remains in good position.The patient was admitted to the hospital for a hypercoagulable work up.

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.

Manufacturer Narrative

A review of the images stated the following: it was reported that a physician implanted a gore cardioform asd occluder successfully.During follow up imaging of the device, thrombus was visualized attached to the right atrial disc.From the imaging provided the device appears to be in a good position.The left and right disc appear to be evenly deployed on their respective sides of the atrial septum.The device does not appear to interfere with any other anatomical structure.There does appear to be a vegetation attached to the right atrial disc, the appearance of this is consistent with that of thrombus.The thrombus appears to protrude into the right atrium.Per the reporting physician the patient was admitted for hypercoagulable work up.

Manufacturer Narrative

Updated section b5.

Event Description

It was reported, the physician implanted a 32mm gore® cardioform asd occluder on (b)(6)2021, to close an atrial septal defect (asd).The device was implanted with no issues.At a two-week follow-up echocardiography, the device was in good position with no thrombus.On (b)(6) 2021 a pedunculated thrombus was noted on the inferior edge of the right disc.The device remains in good position.The patient was admitted to the hospital for a hypercoagulable work up.On (b)(6) 2021, the patient was started on lovenox.On (b)(6) 2022, the device was visualized with no residual shunt, or obstruction to av valves or venous return.No thrombus seen on echo.Lovenox was discontinued on (b)(6) 2022.The patient will continue on asa for 6 months.

• Brand Name: GORE® CARDIOFORM ASD 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13093763
• MDR Text Key: 282822572
• Report Number: 2017233-2021-02642
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 16 KG