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

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.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

In the literature article, "arteriovenous hybrid graft with outflow in the proximal axillary vein" (abstracts accepted for presentation during the 34th annual meeting of the southern california vascular surgical society; http://dx.Doi.Org/10.1016/j.Avsg.2016.05.070; annals of vascular surgery; volume 34, july 2016, page 40) the patient presented with end-stage renal disease.A gore hybrid vascular graft with its venous outflow was placed in the proximal axillary vein.The patient developed steal syndrome requiring proximalization of the graft.

• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5826665
• MDR Text Key: 50581385
• Report Number: 2017233-2016-00659
• 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,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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