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

Catalog Number H470045A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 10/31/2018

Event Type  Death  

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 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
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8103304
• MDR Text Key: 128329483
• Report Number: 2017233-2018-00716
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132605958
• UDI-Public: 00733132605958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Catalogue Number: H470045A
• Device Lot Number: 5954962PP022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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): Death
• Patient Age: 77 YR
• Patient Weight: 113