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 Problem Complete Heart Block (2627)

Event Date 12/09/2014

Event Type  Injury  

Event Description

It was reported the physician was implanting a 25mm gore helex septal occluder to close an atrial septal defect.Following lock release and device assessment, the physician advanced the delivery catheter to the right eyelet to remove the retrieval cord.At this point the patient experienced complete heart block.The physician withdrew the delivery catheter to the inferior vena cava (ivc).The patient was treated with atropine and converted to first degree heart block.The delivery catheter was advanced half way from the ivc to the occluder, the retrieval cord was withdrawn, and the delivery catheter was removed.The patient left the procedure room in first degree heart block.One day post-op, the patient was in between first and second degree heart block.Two days post-op, the patient had converted to sinus rhythm.

Manufacturer Narrative

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

• 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: 4380912
• MDR Text Key: 5117522
• Report Number: 2017233-2015-00002
• 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: 12/09/2014

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: 03/31/2017
• Device Catalogue Number: HX2025
• Device Lot Number: 12539540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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): Hospitalization
• Patient Age: 3 YR
• Patient Weight: 17