MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number	H470045A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Exsanguination (1841)
Date of Event	10/31/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
Gore received medwatch # (b)(4) from fda reporting the following: the patient had a 3.75 hour hemodialysis treatment that was terminated at approximately 11:00am.Per the er admission summary, the patient was at home with his spouse, who had left the room.When she returned, the patient was found unresponsive and bleeding from his av graft.911 was called and the patient was transported to the er and admitted at 16:11 where iv fluids and 2 packed red blood cells (prbc) administered.The patient was intubated.He sustained a cardiopulmonary arrest (cpa) in the er.The hospital was in the process of transferring patient to another hospital after resuscitation.During transfer to the ambulance, the patient coded and subsequently expired.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8103304
• Report Number: 2017233-2018-00716
• Device Sequence Number: 1203467
• Product Code: DSY
• UDI-Device Identifier: 00733132605958
• UDI-Public: 00733132605958
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2022
• Device Catalogue Number: H470045A
• Device Lot Number: 5954962PP022
• 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: 11/20/2018
• 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: Death
• Patient Age: 77 YR
• Patient Weight: 113