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

Catalog Number 0650HYB0605A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Test Result (2695)

Event Date 12/30/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, a gore® hybrid vascular graft was implanted in the patient's right upper arm.On (b)(6) 2013, culture revealed very rare enterobacter cloacae in graft tissue and a second type of enterobacter cloacae.On the venous end, few enterobacter cloacae were noted.On the arterial end enterobacter cloacae was noted.On (b)(6) 2013, the gore® hybrid vascular graft was explanted and the infected soft tissue was also excised.

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: 4746734
• MDR Text Key: 19995789
• Report Number: 2017233-2015-00267
• 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

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2014
• Device Catalogue Number: 0650HYB0605A
• Device Lot Number: 10788282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2012
• 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