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

Catalog Number HX2020

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 07/04/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a 20mm gore helex septal occluder to close a multifenestrated atrial septal defect.The patient¿s septal length measured 23mm, and deficient inferior and superior rims were noted.At the time of implant, images showed a residual shunt.The day after implant, echocardiography showed the device had shifted and was impinging the mitral valve.The patient was sent for surgery where the device was removed and the defect was repaired.The patient was doing well following the procedure.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

Manufacturer Narrative

The device was returned for analysis.The size and shape of the occluder were unremarkable.All leaflet material was present and the wire frame was intact.Based on inspection of this device, there is no indication that the reported event was due to design or manufacture of the device.Echocardiographic images and fluoroscopic images were received for evaluation.Intracardiac echocardiographic images on the day of implant demonstrated the atrial septum was thin, aneurysmal, and multi fenestrated.Posterior superior and anterior inferior rims were present and the anterior superior rim was mildly deficient.A 20mm gore helex septal occluder was implanted.A post implant fluoroscopic image revealed part of the right disc was positioned on the left side of the septum.The occluder was in a stable position with a mild superior residual leak.The following day, transthoracic echocardiography revealed the 20mm gore helex septal occluder had embolized into the left atrium and impinged on the mitral valve.

• 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: 3954086
• MDR Text Key: 4627957
• Report Number: 2017233-2014-00367
• 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: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: HX2020
• Device Lot Number: 11670463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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): Required Intervention
• Patient Weight: 4