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

Catalog Number ASD37J

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 10/14/2022

Event Type  Injury  

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 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

On the morning of (b)(6) 2022, a patient underwent treatment to close a 24.4 mm stop-flow balloon sized atrial septal defect with deficient anterior rim and posterior rim using a 44 mm gore® cardioform asd occluder (gca).During the treatment, the 44 mm device was successfully deployed., however a second-degree atrioventricular block was observed.The 44 mm device was removed and the second-degree atrioventricular block disappeared without treatment.An unsuccessful attempt was made to implant a figulla flex ii 27 mm.A left disc was deployed with irregular shape.Also a second-degree atrioventricular block was observed.To fix the shape, a wiggle was performed but the device was dislodged from the atrial septal defect.A final attempt was made to implant a smaller size device and a 37 mm gore® cardioform asd occluder was selected.The device was successfully deployed and locked.After releasing the right atrial disc the posterior inferior side might have been closer to a left atrial disc under a fluoroscopy and a transesophageal echocardiography revealed a 2 - 3 mm leak at the inferior vena cava side.Possibly, the occluder didn't capture a part of a rim.The procedure was finished because the leak was only about 3 mm.On the morning of (b)(6) 2022, within 24 hours from the initial procedure, a transesophageal echocardiography revealed a device embolization around the tricuspid valve.Percutaneous device removal was considered, but subsequently percutaneous device placement was deemed difficult, so surgically the device was removed, and the atrial septal defect was closed.After the transesophageal echocardiography, an electrocardiogram recording was verified and several premature ventricular contractions were recorded on (b)(6) 2022 at 19:00.The premature ventricular contraction was resolved without treatment.

• 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: 15667992
• MDR Text Key: 302360187
• Report Number: 2017233-2022-03423
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD37J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/25/2022
• Date Device Manufactured: 08/16/2022
• 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; Hospitalization
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 15 KG