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

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

Patient Problem Arrhythmia (1721)

Event Date 06/30/2023

Event Type  Injury  

Event Description

¿a case in that activation vector using hd-grid was useful for at after asd closure using gore cardioform¿ ryota higa, et al.Journal of japan association for clinical engineers, no.78 (dp4-8-1), jun 30, 2023.The patient was woman in 70s.The patient underwent an endovascular treatment to close an atrial septal defect using a gore cardioform (gore® cardioform asd occluder).The patient didn¿t have a medical history of an arrhythmia.However, during a follow-up, the patient was conscious about a rapid pulse and the patient visited the emergency room of the hospital.The patient was diagnosed an atrial tachycardia.A catheter ablation was performed.For the catheter ablation, mapping of the atrial tachycardia was performed using advisor tm hd grid.As a result of the mapping, the earliest was near the atrial septal and a focal pattern was showed.Upon the focal site was confirmed using activation vector, it was assumed that the focal site was located a bit above the position which was showed by lat map.Upon the catheter ablation was performed to the position that was assumed by activation vector, the rapid pulse was stopped by 1 point.This position was confirmed by an intracardiac echo, this position was near the place where the gore cardioform was implanted.It was confirmed an arrhythmia was no induced under a pharmacologic stress and the procedure was concluded.For the focal pattern of the atrial tachycardia, as not only lat map but also activation vector was used along with, the position of the focal site was able to be confirmed more accurately and the atrial tachycardia was able to be stopped by minimum ablation point.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device could not be performed as a valid lot number was not provided.Literature title: a case in that activation vector using hd-grid was useful for at after asd closure using gore cardioform source: ryota higa, et al.Journal of japan association for clinical engineers, no.78 (dp4-8-1), jun 30, 2023.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.

Manufacturer Narrative

Added d5.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18381573
• MDR Text Key: 331178932
• Report Number: 2017233-2023-04507
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female