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

Catalog Number HX2025

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Mitral Regurgitation (1964); Complete Heart Block (2627)

Event Date 12/18/2014

Event Type  Injury  

Event Description

It was reported the physician was implanting a gore® helex® septal occluder to close an atrial septal defect.Using transesophageal echocardiography the following measurements were taken: 29mm septal length, 11mm static measurement of the defect, and 13mm balloon sizing of the defect.A 20mm device was implanted, but a large residual shunt was observed.The device was removed and a 25mm device was implanted.Overnight the patient experienced second degree av block and by morning the patient was experiencing heart block.The patient was kept on steroids until he was taken to surgery to remove the device.The morning of surgery the patient was in sinus rhythm, but imaging showed the device had shifted and was impacting the mitral valve with moderate mitral valve regurgitation.The patient was taken to surgery for removal of the device and closure of the atrial septal defect.The surgeon felt the device was too large for the patient¿s heart.Following surgery the patient was doing well.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded, so no engineering investigation could be performed.

• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4438719
• MDR Text Key: 5318311
• Report Number: 2017233-2015-00028
• 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: 12/23/2014

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
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: HX2025
• Device Lot Number: 12394353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: 1 YR
• Patient Weight: 10