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

Model Number ASD32A

Device Problem Biocompatibility (2886)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

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 the physician implanted a 32mm gore® cardioform asd occluder to treat an atrial septal defect on (b)(6) 2022.At the time of implant the device was well seated with no issues reported.At a follow-up, the patient presented with significant mitral regurgitation.Imaging did not confirm device interference with the valves.The device was explanted on (b)(6) 2023.At the time of surgical removal, the device appeared normal.The defect was closed with a patch and the valves appeared to line up better.The physician was not sure if the device led to the mitral regurgitation or if it was the right heart size change after defect closure.

Manufacturer Narrative

H6: added code b15 imaging evaluation: echocardiographic interrogation revealed a moderate size posterior inferior atrial septal defect with some regurgitation at the mitral valve.The defect was measured around 1.22cm, 1.37cm, and 1.46cm respectively and was surrounded with good rims suitable for closure.Fluoroscopic images demonstrated a successful implant with the 32mm gore cardioform asd occluder to close the atrial septal defect.The left and right discs were conformed symmetrically with good separation between the left and right disc over the defect.There were no echocardiographic images available to confirm the final position of the occluder, but it was noted that the occluder was well seated with no issues reported.At discharge, a radiographic chest x ray demonstrated the occluder remained in good position.During the latest visit, it was reported on echo that there was significant regurgitation at the mitral valve.Due to the finding, the occluder was removed and the atrial septum was surgically repaired.

• Brand Name: GORE® CARDIOFORM ASD 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: 16309082
• MDR Text Key: 308912099
• Report Number: 2017233-2023-03690
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• 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,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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: 4 YR
• Patient Weight: 16 KG