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

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Embolism (1829)

Event Date 03/13/2014

Event Type  Injury  

Event Description

This information was received through yet unpublished literature article " a novel system for transcatheter closure of patent foramen ovale: clinical and echocardiographic outcome comparison with other contemporary devices" to appear in canadian journal of cardiology.The article reports the following outcomes at the first clinical follow-up for patients with a gore helex septal occluder implant: one patient had a documented subsequent cerebrovascular accident.This patient had a positive saline contrast shunt with transesophageal echocardiography performed shortly after the event.No other likely source of embolism was identified.

Manufacturer Narrative

No additional information has been provided to gore regarding the reported event.Literature citation: darsaklis k, freixa x, asgar a, ibrahim r, basmadjian a, deguise p, garceau p, a novel system for transcatheter closure of patent foramen ovale: clinical and echocardiographic outcome comparison with other contemporary devices, canadian journal of cardiology (2014), doi: 10.1016/j.Cjca.2014.03.015.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3776629
• MDR Text Key: 4375747
• Report Number: 2017233-2014-00219
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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