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

Catalog Number	HX2025
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	06/03/2019
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.The gore® helex® septal occluder instructions for use list thrombosis or thromboembolic event resulting in clinical sequelae as potential device or procedure-related adverse events.Additionally, the instructions note that patients should be treated with antiplatelet therapy, such as aspirin or clopidogrel bisulfate, for six months post-implant.The decision to continue antiplatelet therapy beyond six months is at the discretion of the physician.In patients sensitive to antiplatelet therapy, alternative therapies, such as anticoagulants, should be considered.
Event or Problem Description
It was reported the physician implanted a 25mm gore® helex® septal occluder to close a patent foramen ovale on (b)(6) 2014 in a patient with a history of stroke.On (b)(6) 2019, the patient presented with a stroke.Transesophageal imaging performed on (b)(6) 2019 showed a thrombus on the left side of the helex® device.The patient was lost to follow-up after the helex® implant and reported he has not been compliant with the recommended anticoagulants.The patient was prescribed anticoagulants and scheduled for follow-up in one month.In (b)(6) 2019, the patient presented with another stroke and left side paralysis.The patient was discharged under hospice care.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8749415
• Report Number: 2017233-2019-00484
• Device Sequence Number: 1690424
• Product Code: MLV
• UDI-Device Identifier: 00733132606993
• UDI-Public: 00733132606993
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/03/2019

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: 04/30/2016
• Device Catalogue Number: HX2025
• Device Lot Number: 11479250
• 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: 07/01/2019
• 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; Disability
• Patient Age: 38 YR
• Patient Weight: 73