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

Catalog Number ASD32A

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Imaging evaluation: upon reviewing the image provided, a gore cardioform asd occluder can be visualized.It appears that the device is still constrained by the locking loop.The right atrial eyelet appears to be malformed as well.It appears to be larger than normal and it might be the tip of the retrieval catheter but without additional imaging, this cannot be confirmed.The cause for device retrieval difficulty cannot be determined.The gore® cardioform asd occluder instructions for states: adverse events associated with the use of the occluder may include but are not limited to: device embolization 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 a 32mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 16mm static and balloon sized to 18.5mm.After several deployments the physician locked the device and the device prolapsed anteriorly and superiorly into the right atrium.The decision was made to remove the device.Upon trying to recapture the device the physician could not get the device to retract into the delivery system.The device appeared to be coaxial and no reason it should not be able to be recaptured.After several minutes of trying to remove the device the retrieval cord broke.The physician attempted to snare the device and it ended up embolizing to the patient's pulmonary artery.It was reported the patient remained stable.The cardiac surgery team at that point decided the patient should go to the operating room for a surgical repair.Surgery was successful and the patient is doing well.

Manufacturer Narrative

Correction to imaging evaluation: the fluoroscopic images revealed the occluder was in an acceptable position to be retrieved with the right eyelets and lock loop aligned coaxial with the delivery system.However, during the retrieval of the occluder, the delivery catheter got kinked near the distal end of the catheter where the distal marker is located.The kink on the delivery catheter prevented the delivery catheter from capturing the right eyelet.Several attempts were made to capture the right eyelet into the delivery catheter until the retrieval cord broke.After unsuccessful snaring of the occluder, the occluder migrated to the pulmonary artery.The patient remained stable.The physician decided to send the patient to surgery to have the asd repair.Surgery was successful and patient is doing well.

Manufacturer Narrative

Additional imaging evaluation: in the second fluoroscopy, a gore cardioform asd occluder can be visualized.The video shows the retrieval attempt of the device.When trying to retrieve the device, the device was not coaxial to the catheter.The physician was unable to advance the catheter over the right atrial eyelet.

• 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: 18759996
• MDR Text Key: 336012954
• Report Number: 2017233-2024-04651
• Device Sequence Number: 1
• Product Code: MLV
• 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,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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: 4 YR
• Patient Sex: Female