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

Catalog Number HX2035

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Palpitations (2467)

Event Date 03/21/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4) information requested but not provided.(b)(4).

Event Description

It was reported to gore a 35 mm gore® helex® septal occluder was selected to close an atrial septal defect on (b)(6) 2013.The patient reports that since that time she has been experiencing daily symptoms of shortness of breath, chest pain, dizziness and palpitations.The patient has requested that the device be removed; however, the treating physician does not believe this is necessary.The patient sought treatment from another physician and it was reported the device was removed on (b)(6) 2018.It was reported the procedure went well and the device appearance was normal.

• 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: kathy titus ; 9285263030
• MDR Report Key: 7365597
• MDR Text Key: 103308083
• Report Number: 2017233-2018-00183
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: HX2035
• Device Lot Number: 10207868
• 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: 04/03/2012
• 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): Hospitalization; Other
• Patient Age: 19 YR