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

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

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

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® cardioform 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, intervention for device failure or ineffectiveness and new arrhythmia requiring treatment,.

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 2: a (b)(6) year-old man with klinefelter's syndrome and a history of pfo closure with a gore cardioform device due to platypnea-orthodeoxia syndrome presented to the adult cardiology clinic.In the year since his pfo closure, he had developed supraventricular tachycardia (svt) requiring ablation, atrial fibrillation requiring medical management with beta blockers and anticoagulation, and he had continued to experience shortness of breath and had documented desaturations with minimal exercise.Right heart catheterization at an outside hospital showed he had developed heart failure with preserved ejection fraction (hfpef).Tte showed continued atrial right- to- left shunting.At cardiac catheterization, initial ice showed the device's left disk capturing the primum septum.However, the right disk was within the pfo tunnel and did not capture the secundum septum.In addition, an atrial septal aneurysm was present.As assessed by the sizing balloon, the residual pfo tunnel was 5 mm in diameter and 11 mm in length.The secundum suture of the noblestitch¿ el was used to capture the secundum atrial septum.Next, the primum suture was used to capture the superior margin of the cardioform device, effectively serving as the primum septum.Following kwiknot deployment, angiography showed a blind-ending tunnel.By contrast ice, there was a trivial residual shunt.At six month follow-up, repeat ctte both at rest and with valsalva showed no residual shunting.The patient has now experienced complete resolution of symptoms.He continues on anticoagulation and beta- blockers for management of his underlying atrial fibrillation, but has not had any episodes of palpitations since prior to the procedure.Case 1 in the article is captured in case (b)(4).

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12318763
• MDR Text Key: 266413158
• Report Number: 2017233-2021-02258
• 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: 58 YR