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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: chaudhry- waterman n, shapiro s, thompson j.Use of the noblestitch¿ el for the treatment of patients with residual right- to- left shunt following device closure of pfo.Clin case rep.2021;9:1929¿ 1932.Https://doi.Org/10.1002/ccr3.3906.Additional information was requested from the author but was not provided.The gore® helex® septal occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: repeat procedure to the septal defect and intervention for device failure or ineffectiveness.

Event Description

This information was received through literature article "use of the noblestitch¿ el for the treatment of patients with residual right- to- left shunt following device closure of pfo" published clinical case rep.2021.The articles objective/aim is to report the successful use of the noblestitch¿ el to close residual defects in two patients who remained symptomatic after device partial pfo closure.The article reports case 1: a (b)(6) year- old woman, with no significant medical history, initially presented at age (b)(6) with complaints of chest pain and shortness of breath.Platypnea orthodeoxia syndrome was diagnosed, and pfo closure was attempted with a gore helex occluder.Symptoms decreased initially, but later increased to baseline levels.Extensive pulmonary evaluation and chest ct scan were normal.Ctte showed early left heart opacification following agitated saline injection.Transcranial doppler evaluation showed grade 4 right- to- left shunting at rest, grade 5 out of 5 with valsalva maneuver.At cardiac catheterization, initial intracardiac echocardiography (ice) showed the disks of the helex occluder on appropriate sides of the atrial septum.However, the superior portion of the right atrial disk was not opposed to the atrial septum.The residual defect measured 4 mm as assessed by the sizing balloon.Rather than attempting to place an additional double-disk device, we used the noblestitch¿ el system to close the residual defect.The secundum system was used to capture the superior margin of the secundum atrial septum.Next, the primum system of the device was used to capture the superior margin of the left atrial disk of the helex device and oppose it to the secundum atrial septum.The noblestitch¿ el kwiknot was deployed, securing the sutures and closing the residual pfo.Angiography and contrast ice during the procedure, performed both with and without simulated valsalva, and ctte six months post-procedure demonstrated no residual shunt.At the time of her six- month follow- up, the patient reported having experienced immediate resolution of symptoms and has since competed at a high level in masters swimming.Case 2 in the article is captured in case (b)(4).

• Brand Name: GORE HELEX 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12318656
• MDR Text Key: 266407869
• Report Number: 2017233-2021-02257
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 07/26/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR