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

Catalog Number GSXE0025

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

Patient Problems Arrhythmia (1721); Thrombus (2101)

Event Date 04/23/2017

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use list new arrhythmia requiring treatment and thrombosis or thromboembolic events resulting in clinical sequelae as potential device or procedure related adverse events.Literature citation: bovin a.Et al.: doac after pfo closure © am j case rep, 2020; 21: e922467.

Event Description

This information was received through literature article "direct oral anticoagulants after percutaneous patent foramen ovale (pfo) closure: a call for caution" published in the american journal of case reports, available online 20 april 2020.The article reports a (b)(6)-year-old woman presented with a cryptogenic stroke.Echocardiography revealed a patent foramen ovale.The septal defect was closed percutaneously using a 25mm gore® septal occluder with optimal positioning and without immediate complications.The patient was discharged on aspirin monotherapy.Three weeks later, she presented with atrial fibrillation.A direct oral anticoagulant (doac) (rivaroxaban 20 mg once daily) was initiated and aspirin was discontinued.After 4 months of follow-up, a routine echocardiography revealed large thrombi attached to both sides of the occluder.Doac was discontinued and the antithrombotic treatment was switched to warfarin combined with aspirin, and partial thrombus resolution was seen another 4 months later.Due to incomplete thrombus resolution at 1-year follow-up, warfarin was replaced by low-molecular-weight heparin administered subcutaneously, resulting in thrombus resolution 3 months later.The patient is asymptomatic now and did not have thromboembolic complications in the course after device implantation.

• Brand Name: GORE CARDIOFORM SEPTAL 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: 10329228
• MDR Text Key: 200776987
• Report Number: 2017233-2020-01055
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2016
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 75