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

Catalog Number 0650HYB0810A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/29/2016

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

On (b)(6) 2016, a patient was implanted with a gore® hybrid vascular graft in an arteriovenous access application.The procedure was performed in the patient's upper arm, from axillary artery to axillary vein.It was reported that within 24 hours, the patient presented with arterial steal syndrome.On (b)(6) 2016, the vascular graft was ligated and a venous catheter was placed.

Manufacturer Narrative

(b)(4).Review of device manufacturing record history did confirm device met pre-release specifications.

• Brand Name: GORE® HYBRID 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: 6109637
• MDR Text Key: 60180454
• Report Number: 2017233-2016-00846
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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: 03/10/2019
• Device Catalogue Number: 0650HYB0810A
• Device Lot Number: 14859167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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