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

Model Number GSX0025A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Visual Impairment (2138)

Event Date 07/26/2022

Event Type  Injury  

Event Description

A patient called gore customer service and reported that they had a 25 mm gore® cardioform septal occluder implant (implant date of (b)(6) 2020).The patient further reported that they are still having strokes and the device is part of the reason her vision is impaired.Further information provided by the patient suggests neurologist confirmed strokes and transient ischemic attacks.Additionally, a septal shunt was noted (transcranial doppler showed bubbles suggesting a septal shunt).To date, gore does not have confirmation that the shunting is device related.

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use note stroke or tia as a potential device or procedure related event.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: 15244932
• MDR Text Key: 298114172
• Report Number: 2017233-2022-03226
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Date Device Manufactured: 07/29/2019
• 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 Age: 48 YR
• Patient Sex: Female