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

Catalog Number HX2025

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Abnormal Blood Gases (1034)

Event Date 03/18/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted so no engineering investigation could be performed.The image review stated that from the limited fluoro imaging provided the gore helex septal occluders left and right atrial discs appear not to be on the appropriate sides of the atrial septum.A portion of the right atrial disc appears to be on the left atrial side, however, without echocardiography and the limited fluoroscopy imaging provided this cannot be confirmed.A catheter appears to cross through the device from the right atrial side to the left atrial side.This is consistent with a communication between the two atriums still being present.Per the performing facility a cribriform device was implanted and the patient was doing well following the procedure.(b)(4).Udi: (b)(4).

Event Description

It was reported the physician implanted a gore® helex® septal occluder in (b)(6) of 2015 to close a patent foramen ovale.Approximately three years post implant the patient presented with orthodeoxia.The device was imaged and a residual shunt was seen.To close the residual shunt the physician implanted a cribriform device.The patient was doing well following the procedure.

• Brand Name: GORE® HELEX® SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7520614
• MDR Text Key: 108489066
• Report Number: 2017233-2018-00284
• 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
• Report Date: 04/18/2018

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: 05/31/2017
• Device Catalogue Number: HX2025
• Device Lot Number: 12725894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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: 56 YR
• Patient Weight: 106