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

Model Number GSX0030A

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The following information was obtained through the clinical study (b)(6): it was reported the physician implanted a gore® cardioform septal occluder on (b)(6) 2020.On (b)(6) 2020, the patient was noted to have a paroxysmal supraventricular tachycardia (psvt).The study site notes that treatment was provided by the health care professional but does not specify what.On (b)(6) 2020, echocardiography performed and beta blocker medication started along with holter monitor.

Manufacturer Narrative

Updated event description in section b.Added new patient code.

Event Description

It was reported the physician implanted a gore® cardioform septal occluder on (b)(6), 2020.On (b)(6), 2020, the patient was noted to have a paroxysmal supraventricular tachycardia (psvt).The study site notes that treatment was provided by the health care professional but does not specify what.On (b)(6) 2020, echocardiography performed and beta blocker medication started along with holter monitor.In the clinical data base the patient arrhythmia was updated to atrial fibrillation (b)(6), 2020, following holter monitor.Started subject on amiodarone and apixaban.

• 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
• MDR Report Key: 11108585
• MDR Text Key: 224788436
• Report Number: 2017233-2021-01567
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 136