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

Catalog Number ECH460045J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia (1942)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.The explanted device was discarded at user facility.Therefore, direct product analysis was not possible.

Event Description

The following was reported to gore: in (b)(6) 2018 (exact date unknown), a patient was implanted with a gore® acuseal vascular graft in the patient's left upper arm as an arteriovenous shunt for hemodialysis.On (b)(6) 2018, an explant procedure was performed due to suspected arterial steal syndrome.The patient underwent artery superficialization method and the arterial steal symptom was resolved.

Event Description

On (b)(6), arterial steal syndrome was suspected.On (b)(6), intervention was performed.

Manufacturer Narrative

B3: date of event was corrected to onset date instead of intervention date.B5: event description updated.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8122374
• MDR Text Key: 129022217
• Report Number: 2017233-2018-00729
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: ECH460045J
• Device Lot Number: 6006034PP021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 80