MAUDE Adverse Event Report: W.L. GORE GORE HELEX SEPTAL OCCLUDER

Model Number HX2025

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

Patient Problems Tachycardia (2095); Ventricular Tachycardia (2132); Complete Heart Block (2627)

Event Date 07/24/2017

Event Type  Injury  

Event Description

This isn't my first report to the fda (which i never heard back but have proof i reported - proof for which i'm sending to my congressman) about gore helix closure device inserted (b)(6) 2012 for pfo.Had arrhythmia.She went into third degree heart block, worsening tachycardia, exercise intolerance svt and now diagnosed with pots.I'm getting worse not better and it's all arrhythmia related since i got the device implanted.I've also communicated this with the company itself.I want answers.I want investigation done on this device.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Type of Device: GORE HELEX SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE
• MDR Report Key: 6784779
• MDR Text Key: 82504827
• Report Number: MW5071467
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: HX2025
• Device Catalogue Number: REF
• Device Lot Number: 10529347
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Weight: 92