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

Catalog Number GSXE0025

Device Problems Patient-Device Incompatibility (2682); Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

H3, "other" code: the explanted device was reportedly discarded at the facility.Therefore, an explant evaluation of the device cannot be performed.H6, investigation findings, code c19: the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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.

Event Description

It was reported to gore that on (b)(6) 2023, a 25mm gore® cardioform septal occluder was selected to treat an iatrogenic atrial septal defect following a mitral valve clip procedure and measuring 5 mm.Reportedly, the device was implanted with a good outcome.However, the follow-up scan prior hospital discharge showed the right disk appearing bulky in the right atrium.Subsequent fluoroscopy imaging displayed the device locked and not impinging on flow or structures.On (b)(6), 2023, and following another follow-up scan, the device was surgically removed and replaced with an alternative device.The patient tolerated the procedure.

Event Description

On march 22, 2023, and following another follow-up scan, the device was surgically removed and replaced with an alternative device.No clinical sequelae for the patient were reported.

Manufacturer Narrative

B5, describe event or problem: additional information.H6 evaluation codes: codes were added/updated to reflect the extent of the investigation performed.An electronic file containing a digital cine fluoroscopy image was returned to gore and an imaging evaluation was performed.In the echo image provided, the right disc appears bulbous in nature indicating right disc expansion.Without additional imaging, it cannot be confirmed if the device was in a stable and locked position.The cause for the right disc expansion cannot be determined but it is suspected that there was tricuspid regurgitation that contributed to the right disc expansion.Adverse events associated with the use of the occluder may include, but are not limited to: occluder disc expansion resulting in clinical sequelae or intervention.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

• 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: 16781868
• MDR Text Key: 313706868
• Report Number: 2017233-2023-03876
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 92 YR
• Patient Sex: Female
• Patient Weight: 51 KG