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

Catalog Number ASD37J

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

Patient Problem Arrhythmia (1721)

Event Date 03/23/2023

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, the patient underwent treatment to close a 19.4mm sized atrial septal defect using a 37 mm gore® cardioform asd occluder.After the left atrium disc was deployed, the right atrium disc was attempted to deploy but it was not deployed in intended position.The right disc was reloaded and deployed again.It was confirmed that there was no issue by tee and fluoroscopy.Upon the device being locked, it shifted 90°.It was confirmed that there was no issue by fluoroscopy; however, tee revealed that the edge of the right atrium disc was touching the aorta side of the right atrium and it seemed that the edge of the disc was pushing the aorta.The physician decided to remove the occluder.Before removing the occluder, considering the possibility of the control catheter gave a tension to the device, the retrieval lure was loosed and the device was pushed a bit.The device shape was improved but the handle was pulled accidentally and the left disc was dropped in the right atrium.The device was attempted to be retrieved, but the left atrium eyelet was not able to be pulled into the sheath completely.A 12fr long sheath was inserted from the lfv to the ostium of the ivc and a snare catheter was used and the snare catheter could grab the edge of the device and the device was pulled into the 12fr sheath.The 12fr sheath was removed completely.When the guidewire was advanced to the left atrium to implant another occluder, it was noticed that a third-degree atrioventricular block was occurring.The former record was reviewed a bit, it seemed that the third-degree atrioventricular block occurred a bit before the 37 mm gore® cardioform asd occluder was removed completely.The medication was started and the physician waited and saw a while, but the third-degree atrioventricular block was not completely improved.The physician decided to redo the procedure on another date.The physician stated that he didn¿t think the gore® cardioform asd occluder could pass thorough the aorta but he felt anxious about to implant the occluder as planned when he saw tee image.

• 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: 16691041
• MDR Text Key: 312821697
• Report Number: 2017233-2023-03847
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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
• Date Manufacturer Received: 03/23/2023
• Date Device Manufactured: 12/07/2022
• 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: 7 YR
• Patient Sex: Female
• Patient Weight: 22 KG