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

Catalog Number ASD44J

Device Problem Fracture (1260)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/22/2023

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

The following was reported to gore: on (b)(6), 2023, a patient underwent treatment to close a 23 mm stop-flow balloon sized atrial septal defect with deficient aortic rim and superior rim using 44 mm gore® cardioform asd occluder (gca).On (b)(6), 2023, the patient returned for 3-month follow up.An echo revealed a mitral regurgitation, therefore, an radiograph was performed.The radiograph revealed wire frame fracture of the occluder.A possibility that the fracture had caused damage to the mitral valve was considered.On (b)(6), 2023, a thoracotomy was performed.The damaged mitral valve was treated with direct closure and the occluder was removed then the atrial septal defect was treated.The patient tolerated the procedure.Reportedly, at one (1) month follow up, any wire frame fracture was not confirmed.

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: device fracture resulting in clinical sequelae or surgical intervention.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Imaging evaluation: the radiograph revealed wire frame fracture of the occluder.Upon looking at the images provided, there is initial concern on the date of implant of the device around the inferior/posterior rim.There is not clear separation of the inferior margin between the left and right discs.It appears as there is a prolapse of right disc into the fossa ovalis.It is also important to note that the device selected was greater than 90% of the total septal length.The septal length provided by the physician was 35 mm.At the one month follow up xray image provided, a wire frame fracture can be seen inferiorly on the device.At the three month follow up, the fracture of the frame appears to be more significant.In fluoro images the wire frame fracture is visualized.There is not separation of the device around the inferior/posterior portion of the device.It is suspected that the missed inferior margin of the device allowed the device to settle into the fossa ovalis and due to the contraction of the heart on the petals of the device as opposed to the proper placement which would allow contraction around the waist of the device is what caused the frame fracture.However, this cannot be confirmed.Explant evaluation: multiple areas of disrupted leaflet material were present on both disc surfaces and within the intra-disc waist region.A total of nine wire discontinuity pairs (18 total wire discontinuity ends) were present.The exact time and cause of the disruptions could not be determined.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18334102
• MDR Text Key: 330553744
• Report Number: 2017233-2023-04473
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD44J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 25 KG