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

Catalog Number ECH470045A

Device Problem Infusion or Flow Problem (2964)

Patient Problem Stenosis (2263)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Device remains implanted; therefore, direct analysis was not possible.

Event Description

On (b)(6) 2016, a gore® acuseal vascular graft was implanted in a patient's arm in an arteriovenous application.As reported, the vascular graft was cannulated for the five dialysis treatments.During the most recent dialysis treatment, the vascular graft appeared to be thrombosed.On (b)(6) 2016, a reintervention procedure revealed low blood flow but no thrombosis.Stenosis was observed at the arterial and venous anastomoses.A regular, non-high pressure pta balloon was used to resolve the stenosis.

• Brand Name: GORE® ACUSEAL 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5546314
• MDR Text Key: 41818587
• Report Number: 2017233-2016-00316
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2018
• Device Catalogue Number: ECH470045A
• Device Lot Number: 4903993PP009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2015
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 87