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

Catalog Number 0650HYB0705A

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

Patient Problem Staphylococcus Aureus (2058)

Event Date 06/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a gore® hybrid vascular graft was implanted in a dialysis patient.A partial graft removal was done on (b)(6) 2014 as cultures revealed moderate staph aureus was present.Blood cultures showed no growth.It was reported patient had a wound with very rare staph lugdunensis.On (b)(6) 2015, the remaining gore® hybrid vascular graft was explanted as culture drawn revealed wound staph aureus staph lugnensis.Blood cultures showed no growth.

Manufacturer Narrative

Review of device manufacturing and sterilization record history confirmed 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 86004 ; 9285263030
• MDR Report Key: 4741263
• MDR Text Key: 5703238
• Report Number: 2017233-2015-00262
• 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
• Report Date: 04/10/2015

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: 01/08/2015
• Device Catalogue Number: 0650HYB0705A
• Device Lot Number: 11023928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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