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

Catalog Number H470045A

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 12/18/2013

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Medwatch #2017233-2015-00272 was submitted for the gore® hybrid vascular graft (unknown lot number) implanted (b)(6) 2015.Review of device manufacturing and sterilization record history confirmed device met pre-release specifications.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4757364
• MDR Text Key: 5790154
• Report Number: 2017233-2015-00271
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• 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: 04/30/2017
• Device Catalogue Number: H470045A
• Device Lot Number: 4116080PP009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2013
• 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