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

Model Number GSX0030A

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

Patient Problems Fever (1858); Rash (2033); Chills (2191); Thrombosis/Thrombus (4440)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported to gore by a caller from pike peak allergy and asthma that they are calling on behalf of the patient to see what type of metal the gore septal occluder is made of.The patient is getting allergy tested for metal due to having an allergic reaction to the device.It was reported a 30mm gore® cardioform septal occluder was implanted on (b)(6) 2022 to treat a defect.It was reported the following day the patient experienced fever, chills and a rash.It was also reported blood clot or thrombus (unsure) were noted near the device and it is being determined how to treat it.On (b)(6) 2022, the product specialist spoke to the allergist and received additional information and a text with some images.The blood clot and allergy are being medically treated with anticoagulants and steroids.2412-a: dissatisfaction/non-specific is being used for: fever, chills and a rash.

Manufacturer Narrative

Patient age, gender, weight was requested but not available.Additional information was requested but not provided.The device remains implanted, therefore, an engineering evaluation could not be performed.The imaging evaluation states: in the echo imaging provided, it shows that the device is stable and well apposed to the atrial septum.It appears that the device is in a satisfactory position and that the left atrial disc appears flat and well apposed to the atrial septum.The right disc is well apposed to the septum.The appearance of a small right disc expansion is visualized on the echo images provided.There does not appear to be any thrombus or clots on the device.This cannot be confirmed without additional imaging.It was reported that the patient had experienced an allergic reaction to the device and will be treated with steroids and anticoagulation therapy.At this time, the device is being left in.The gore® cardioform septal 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.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13789513
• MDR Text Key: 287541597
• Report Number: 2017233-2022-02808
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Date Device Manufactured: 07/13/2021
• 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