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

Catalog Number	HX2025
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported a patient received a gore® helex® septal occluder implant in 2015 to treat a patent foramen ovale.Approximately two months ago a significant shunt was noted and it appeared as though a couple of the right disc leaflets had prolapsed.A 25mm gore® cardioform septal occluder was selected to close the shunt; however, following deployment a significant residual shunt was noted on echocardiography and the device was removed.A 30mm gore® cardioform septal occluder was then selected, however, when the device was locked, fluoroscopy revealed a missed right atrial eyelet.This device was removed and a second 30mm gore® cardioform septal occluder was successfully implanted.The gore® helex® septal occluder also remains implanted.Further discussion between the field sales associate and the physician indicated it was felt that this was another defect/fenestration; however, this has not been confirmed.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8233140
• Report Number: 2017233-2019-00012
• Device Sequence Number: 16550380
• Product Code: MLV
• UDI-Device Identifier: 00733132606993
• UDI-Public: 00733132606993
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: HX2025
• Device Lot Number: 13533244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 105