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

Catalog Number HX2030

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Unspecified Infection (1930)

Event Date 10/08/2014

Event Type  Injury  

Event Description

It was reported a gore helex septal occluder was implanted on (b)(6) 2013.On (b)(6) 2014, the patient presented with multiple strokes.Imaging of the implant showed growths throughout the device, with large growths on the left atrial disc.It was determined to be infection and the device was surgically removed.The patient remains in rehabilitation due to the strokes.

Manufacturer Narrative

A review of the manufacturing and sterilization records verified the lot was processed normally and all pre-release specifications were met.The device was discarded at the site and therefore a device analysis cannot 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4707153
• MDR Text Key: 19503208
• Report Number: 2017233-2015-00242
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: HX2030
• Device Lot Number: 10630173
• 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: 09/10/2012
• 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: 38 YR