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

Catalog Number IRTH064040J

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problems Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pseudoaneurysm (2605)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

On an unknown date in (b)(6) 2015, a gore® propaten® vascular graft was implanted during a femoral-popliteal artery bypass surgery.On an unknown date in (b)(6) 2016, a pseudo aneurysm was found at the anastomosis of the right femoral artery, and the pseudo aneurysm was removed surgically.On an unknown date in (b)(6) 2016, a new pseudo aneurysm was identified on the same site, and infection was suspected.No reintervention was performed.On an unknown date, a rupture of the pseudo aneurysm was identified and it was treated with a covered stent (unknown manufacturer).On (b)(6) 2017, a graft infection was identified, skin fistula and the exposure of the graft were reported.The patient was treated with antibiotic medication and is being monitored.No explant has been performed.

Manufacturer Narrative

Country ((b)(6)) was inadvertently left off in initial medwatch report.Corrected to 'serious injury'.

• 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 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6642061
• MDR Text Key: 77744028
• Report Number: 2017233-2017-00299
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IRTH064040J
• 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