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

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

Patient Problem Arrhythmia (1721)

Event Date 10/02/2023

Event Type  Injury  

Event Description

The following literature article was reviewed: fumanelli, j., garibaldi, s., castaldi, b., di candia, a., pizzuto, a., sirico, d., cuman, m., mirizzi, g., marchese, p., cantinotti, m., piacenti, m., assanta, n., viacava, c., di salvo, g.And santoro, g.(2023) ¿mid-term electrical remodeling after percutaneous atrial septal defect closure with gco device in a pediatric population,¿ journal of clinical medicine, 12(19), p.6334.Doi: 10.3390/jcm12196334.The aim of this multi-center, prospective study was to evaluate the short- and medium-term electrocardiographic changes after percutaneous atrial septal defect (asd) closure with gore® cardioform septal occluder (gco) in a pediatric population.From (b)(6) 2020 to (b)(6) 2021, (b)(4) patients with a median age of 7 years with isolated asd submitted to trans-catheter closure.The gco device was successfully implanted in all patients.At the baseline ecg, cardiac rhythm was sinus in all patients, but one case showed low atrial rhythm.Asd closure resulted in a marked decrease in right heart volumes and diameters at 6 months after percutaneous closure.After device deployment, two patients developed transient, self-limited junctional rhythm.One of them needed a short course of flecainide for atrial ectopic tachycardia.No tachy/brady-arrhythmias were recorded at the 6-month follow-up.In the study, only one of the patients showed arrhythmias of intracardiac conduction abnormalities during a mid-term follow-up.One patient showed a burst of focal atrial tachycardia early after device implantation that was effectively treated with a short course of flecainide.This complication could have been due to both the large size of the device and the shortness of the surrounding rims.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2: the median age among the patients was reported to 7 years.B3: the date of event is unknown.Therefore, the online publication date of the literature article is used as date of event.Literature citation: fumanelli, j., garibaldi, s., castaldi, b., di candia, a., pizzuto, a., sirico, d., cuman, m., mirizzi, g., marchese, p., cantinotti, m., piacenti, m., assanta, n., viacava, c., di salvo, g.And santoro, g.(2023) ¿mid-term electrical remodeling after percutaneous atrial septal defect closure with gco device in a pediatric population,¿ journal of clinical medicine, 12(19), p.6334.Doi: 10.3390/jcm12196334.H3 other code, and h6 code b20: engineering evaluation could not be performed as the device remains implanted.Gore has requested a device identification and other patient related data from the corresponding author.If provided, manufacturing records will be followed.The gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: new arrhythmia requiring treatment.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

Gore has made multiple attempts to requested device identification and other patient related data from the corresponding author.The author was not able to provide any additional information.Review of the manufacturing records could not be performed as a valid lot number was not provided.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.H6: updated e0601 to e060109.Added b22.Updated c21 to c19, updated d16 to d15 and d12.

• Brand Name: GORE® CARDIOFORM SEPTAL 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18966878
• MDR Text Key: 338429639
• Report Number: 2017233-2024-04741
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 7 YR