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

Catalog Number ASD48J

Device Problem Migration (4003)

Patient Problem Arrhythmia (1721)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use list device embolization as a potential device or procedural-related adverse event.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, the patient underwent treatment to close a 27mm atrial septal defect using a 48mm gore® cardioform asd occluder.Additionally, the patient had a deficient anterior rim.The occluder was implanted successfully and the procedure was concluded.When the patient attempted to return to the room, the patient was coughing and a premature ventricular contraction was observed and an abnormal electrocardiogram occurred.Transthoracic echocardiography revealed that the occluder had prolapsed into the right atrium.A procedure to remove the occluder was performed.The occluder was removed from the patient with a snare.After the occluder was removed, a non-gore device (ffii) was attempted but a shunt remained; therefore, the percutaneous closure treatment was abandoned.The future treatment plan has not yet been determined.The physician stated that the length of superior vena cava rim covered by the left atrial disc was deficient and therefore the occluder may have been undersized.

• 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: 17755556
• MDR Text Key: 323502467
• Report Number: 2017233-2023-04278
• 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
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD48J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Date Device Manufactured: 06/08/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male