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 Staphylococcus Aureus (2058)

Event Date 01/23/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012 a gore® helex® septal occluder was implanted.On (b)(6) 2015 the patient presented with a staph infection.The device looked fine and iv antibiotics were administered for two weeks.After two weeks the patient returned to normal but another look at the device revealed vegetation on the left disc.The patient is scheduled for removal of the device on (b)(6) 2015.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Manufacturer Narrative

A review of the sterilization records for the device verified that the lot met all pre-release specifications.An echocardiographic image was received by gore for review.Upon review of the image, there appears to be an echogenic mass attached to a septal occluder in the left atrium.

• 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: 4570078
• MDR Text Key: 5552862
• Report Number: 2017233-2015-00132
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: HX2025
• Device Lot Number: 10549811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2012
• 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: 58 YR