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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/08/2022

Event Type  Injury  

Event Description

This information was received through literature article "formation of large thrombus on cardioform atrial septal occluder device: late complication and successful surgical treatment¿ published in the journal of the american college of cardiology, 8 march 2022.This article reports a case of a (b)(6) female with history of permanent cardiac pacemaker and multiple cryptogenic strokes underwent patent foramen ovale (pfo) closure with a 25mm gore® cardioform septal occluder.Post procedure medical therapy included apixaban for a diagnosis of atrial lead thrombus.Follow up transesophageal echocardiogram (tee) -at 3 months- revealed thrombus on right atrial side of a well-positioned pfo closure device with no shunt.Anticoagulation changed to warfarin, but she was noncompliant.Tee -at 6 months- revealed resolution of right-side thrombus but a new large pedunculated thrombus attached to the middle of left atrial disc.Given the large thrombus size, surgical removal of the thrombus was performed.The device was well positioned and endothelialized except for a small mid-segment of atrial disc which was covered with a small pericardial patch.She tolerated the surgery well and was discharged home days later on warfarin.Our case is unique, as the thrombus was large and noted to form on a small area that neoendothelialisation was not complete.This case highlights the risk of delayed endothelialisation and need for further studies of the optimal duration and type of antithrombotic therapy post device implantation.

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use note thrombosis or thromboembolic events resulting in clinical sequelae, including pharmaceutical therapy as a potential device or procedure related adverse event.Literature citation: ziad sayedahmad, zachary oman, sundeep kumar, ali ahmad, sunil prasad, elsayed abo-salem, formation of large thrombus on cardioform atrial septal occluder device: late complication and successful surgical treatment, journal of the american college of cardiology, volume 79, issue 9, supplement, 2022, page 2844, issn 0735-1097, https://doi.Org/10.1016/s0735-1097(22)03835-9.Additional information regarding this report was requested; however, to date, the author contacted has not responded.The event date is unknown and the article publication date is being used as the event date.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 15041856
• MDR Text Key: 296062768
• Report Number: 2017233-2022-03132
• Device Sequence Number: 1
• Product Code: MLV
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/18/2022
• 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: 60 YR
• Patient Sex: Female