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

Catalog Number ECH060040J

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be conducted since the requested lot number is not available.

Event Description

On an unknown date, around 2018 to 2019, the patient was implanted with a gore® acuseal vascular graft as an av shunt for hemodialysis on the left forearm.On an unknown date in late 2019, a follow-up echo examination showed graft delamination.Graft occlusion was also confirmed at the same site.As a treatment, pta ballooning was performed.On an unknown date, the graft occlusion and the graft delamination were confirmed again at the same site.A reintervention of pta ballooning was performed as treatment.The graft remains implanted and the patient is being monitored.The physician's stated it was not determined if the graft delamination occurred at the puncture site or not.

Manufacturer Narrative

Engineering evaluation task was performed and the results are: the identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The event description could not be confirmed, as no identity or image of the device was provided for evaluation.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9744951
• MDR Text Key: 188376498
• Report Number: 2017233-2020-00125
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention