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

Catalog Number ASD44E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

H3, code "other" - the gore® cardioform asd occluder (asd44e/(b)(6)) is believed to have been discarded as reportedly no implant of the device occurred due to the patients deteriorating condition during the procedure.Code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.A causal relationship between the gore® cardioform asd occluder (asd44e/(b)(6)) and the sudden deterioration of the patient's condition during the procedure is currently unknown.Gore is therefore reporting this incident in an abundance of caution.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 37 mm gore® cardioform asd occluder was selected to treat three atrial septal defects (asds) in a patient with a floppy septum.The two smaller defects were reported to have measured 3 and 7 mm in diameter and a bigger one 17 to 18 mm.Reportedly, during several placement attempts the left disc kept prolapsing into the right atrium.However, the device was eventually confirmed well positioned in the bigger asd by ultrasound and fluoroscopy imaging.Upon locking the device, the physician started to pull the retrieval cord for approximately 1 to 2 cm when the device reportedly prolapsed into the right atrium with the physician attempting at the same time to hold the device in place.It was therefore decided to pull the occluder back into the sheath and retrieve it from the patient.Subsequently, a 44 mm gore® cardioform asd occluder was selected to proceed with the procedure.However, after the first two implantation attempts had failed, the patient's condition suddenly deteriorated and an emergency operation had to be performed.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18474293
• MDR Text Key: 332428146
• Report Number: 2017233-2024-04527
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD44E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Date Device Manufactured: 02/01/2023
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 40 KG