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

Catalog Number HX2025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Complaint, Ill-Defined (2331)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Gore helex septal occluder lot #13279845 (b)(4).

Event Description

It was reported a physician implanted a 25 mm gore helex septal occluder to close a patent foramen ovale on (b)(6) 2015.Recently, the patient presented with tia-like symptoms, migraines, and a general sense of ill-being.A transthoracic echocardiographic bubble test was performed, showing a shunt; however, it was unclear if it was a septal shunt.On (b)(6) 2017, transesophageal echocardiography and x-ray imaging confirmed a septal shunt.The helex device appeared stable and it was difficult to tell if it had shifted post-implant.A gore cardioform septal occluder was implanted over the helex device to close the shunt.The device was well seated with no residual shunt and the patient was doing well following the procedure.

Manufacturer Narrative

Electronic files containing digital cine fluoroscopy runs and echocardiography images were received for review.From the echocardiography imaging provided, it appears the anterior portion of the gore helex septal occluder was deployed, or had shifted into the tunnel portion of the patent foramen ovale.This allowed for a residual shunt between the left and right atriums.Without imaging from the initial deployment, the exact cause of the occluder¿s position could not be ascertained.A gore cardioform septal occluder was deployed across the residual shunt.From the imaging provided, it appears to be stable and in a good position.Both the right and left atrial discs are evenly deployed on their respective sides of the atrial septum and overlap the previously implanted gore helex septal occluder.The residual shunt is no longer present.

• 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 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6312225
• MDR Text Key: 66824921
• Report Number: 2017233-2017-00068
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

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
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: HX2025
• Device Lot Number: 13279845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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
• Patient Age: 36 YR
• Patient Weight: 54