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

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058)

Event Date 12/18/2013

Event Type  Injury  

Event Description

Patient was implanted with a gore® propaten® vascular graft in an arterio-venous application.On (b)(6) 2013, thrombectomy and a revision procedure using a gore® hybrid vascular graft was performed.On (b)(6) 2013, wound culture revealed moderate staph aureus and blood cultures revealed no growth.On (b)(6) 2013, the gore® hybrid vascular graft was explanted.

Manufacturer Narrative

Medwatch #2017233-2015-00271 was submitted for the gore® propaten® vascular graft implanted on (b)(6) 2013.Device lot number was not made available.Therefore, manufacturing record history could not be reviewed.

• 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: 4757398
• MDR Text Key: 5953071
• Report Number: 2017233-2015-00272
• 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: 05/07/2015
• 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