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

Catalog Number GSXE0030

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2021, this patient was initially implanted with a 30mm gore® cardioform septal occluder as a prophylactic measure to prevent recurrence of cryptogenic stroke.Monotherapy with clopidogrel as antiplatelet treatment was subsequently conducted due to the patient's allergy to aspirin®.In the context of routine transesophageal echocardiogram (tee) follow-up on march 22, 2022, suspected thrombus on the left atrial segment of the occluder device was found.Thus, anticoagulation therapy with edoxaban was started.Ensuing follow-up tee examination on may 12, 2022 showed no accumulation of suspected thrombus on the occluder device.Thereupon, anticoagulation treatment was stopped and a therapy with clopidogrel was started.During another follow-up on july 5, 2022 however, suspected thrombus formation was again found on the left atrial segment of the occluder device and it was reportedly decided that anticoagulation treatment again be commenced.Reportedly, there had not been any clinical event and the patient had not issued any complaints since the implantation of the septal occluder device.

Manufacturer Narrative

The gore® cardioform septal occluder gsxe0030 / 23895526 remains implanted in the patient.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.

Manufacturer Narrative

H6, component code: added imdrf codes g04088, g04027.H6, type of investigation: added imdrf codes b13, b20.H6, investigation conclusions: added imdrf codes d15, d12.A digital cine echocardiography image was returned to gore.The image was evaluated and it was found that a vegetative growth was visualized near the left atrial disc of the gore cardioform septal occluder.The growth does not appear to be mobile and appears to be attached to either the left atrium or the gore cardioform septal occluder.Without additional imaging, imaging is unable to determine if the growth is thrombus formation or a left atrial myoma.Without additional imaging, imaging is unable to determine if the device is in a secure location with appropriate disc separation and the locking is not visualized without x-ray imaging.Per the facility, the patient is not experiencing any issues and the finding was found on transesophageal echocardiogram follow up.Anticoagulation therapy has been restarted.H6, health effect - clinical code: replaced fda code 4440 with imdrf code e0514.H6, health effect - impact code: replaced fda code 4644 with imdrf code f2303.H6, medical device problem code: replaced fda code 2993 with imdrf code a24.H6, type of investigation: replaced fda codes 3331 and 4112 with imdrf codes b14 and b15.H6, investigation findings: replaced fda code 213 with imdrf c19.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15159899
• MDR Text Key: 297191939
• Report Number: 2017233-2022-03183
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female