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

Catalog Number ASD48B

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/20/2021

Event Type  Injury  

Event Description

It was reported the physician implanted a 48mm gore® cardioform asd occluder to treat an atrial septal defect on the (b)(6) 2021.At time of implant, right disc expansion was noted, but the device was locked and stable.On (b)(6) 2021, during the one month post implant follow-up, the physician noted there was still right disc expansion.Imaging also noted a potential clot/thrombus formation.The patient was prescribed warfarin.On (b)(6) 2022, the physician reported that ct imaging showed the device was unlocked.It was further reported that the patient is still taking warfarin which seems to have helped the right disc flatten.

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use list thrombosis or thromboembolic event resulting in clinical sequelae as a potential clinical and device adverse event.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13333758
• MDR Text Key: 284355564
• Report Number: 2017233-2022-02688
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Catalogue Number: ASD48B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female