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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Medical literature citation: anaya-ayala je, davies mg, el-sayed hf, peden ek, naoum jj.Early experience with a novel hybrid vascular graft for hemodialysis access creation in patients with disadvantaged anatomy.Journal of endovascular therapy.In press.(see attachment below).No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

In a medical literature article the gore® hybrid vascular graft was used in disadvantaged anatomy for the purpose of hemodialysis access creation.A comparison was made between the gore® hybrid vascular graft in the outcomes to standard-wall polytetrafluoroethylene (ptfe) grafts.In a retrospective analysis, 25 patients who received the hybrid graft were compared with 35 patients who received a standard ptfe graft for hemodialysis access over a 2-year period.It was stated that 3 of the gore® hybrid vascular graft patients developed arterial steal syndrome.Two patients required plication of the inflow graft segment, and 1 patient required stenting of a proximal brachial artery stenosis to improve inflow.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5053592
• MDR Text Key: 24953425
• Report Number: 2017233-2015-00576
• 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
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• 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