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

Catalog Number	HX2030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombus (2101)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.An echocardiographic image was provided for review.The image showed a well seated and stable gore® helex® septal occluder with an echogenic mass near the center portion of the left atrial disc of the device.The gore® helex® septal occluder instructions for use list thrombosis as a potential device or procedure-related adverse event.
Event or Problem Description
It was reported the physician implanted a 30mm gore® helex® septal occluder on (b)(6) 2014 to close a patent foramen ovale.In (b)(6) 2018, the patient presented with a stroke and echocardiography demonstrated a 7mm mass on the left atrial disc of the helex® device.The patient was placed on coumadin.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8624550
• Report Number: 2017233-2019-00361
• Device Sequence Number: 16740995
• Product Code: MLV
• UDI-Device Identifier: 00733132607006
• UDI-Public: 00733132607006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 06/30/2017
• Device Catalogue Number: HX2030
• Device Lot Number: 12843169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2019
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 135