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

Model Number HX1535

Device Problem Malposition of Device (2616)

Patient Problem Fainting (1847)

Event Date 11/25/2013

Event Type  malfunction  

Event Description

A little over six years ago, a 35mm helex atrial septal occluder was placed in a moderate 13mm secundum atrial septal defect.It appeared appropriately positioned but some movement of the right discs were later recorded but it appeared to be locked appropriately.Patient returned a few months ago because of near syncopal episodes.An echocardiogram demonstrated that the right atrial discs were abnormally positioned in the right atrium.A brain mri only demonstrated a subacute lacunar defect.A tee (transesophageal echo) demonstrated malposition of the right lower and upper discs.The right lower disc was apparently pushed up by flow from the inferior vena cava and the right upper disc pushed out by a 2.5cm thick lipomatous septum secundum.There was no evidence of residual atrial shunt by color flow or agitated contrast saline injections.Device fluoroscopy and chest ct confirmed the abnormal position of the right discs and the lipomatous atrial septum.There was not evidence of fracture of the disc wires and the right discs were appropriately locked by the locking mechanism.The left disc was appropriately positioned on the left side of the atrial septum.There was no apparent explanation for the abnormal position of the lower right atrial disc.A tilt test was normal and the patient had no further symptoms.She returned home with no further therapy to have continued observation and follow up in 6 months.

• Brand Name: HELEX ATRIAL SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86003
• MDR Report Key: 3636404
• MDR Text Key: 4178054
• Report Number: 3636404
• Device Sequence Number: 1
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: HX1535
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1