MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJ071002

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/08/2015

Event Type  Injury  

Manufacturer Narrative

Lot: 12105071 (b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2014, a gore viabahn endoprosthesis was placed as a branch device into the left renal artery.It was reported to gore that on (b)(6) 2015, a type ib endoleak was discovered at the distal end of the graft.There was reported a flow of contrast around the distal end of the stent graft back into the aneurysm sac.A reintervention procedure was performed with placement of new left renal artery stents.An 8mm x 5cm gore viabahn endoprosthesis was used to extend the old stent distally into the left renal artery and was reinforced with a bare metal stent.The results were a patent left renal artery with exclusion of the endoleak.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5051742
• MDR Text Key: 24903142
• Report Number: 2017233-2015-00573
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: VBJ071002
• Device Lot Number: 12105071
• 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: 01/09/2014
• 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
• Patient Age: 77 YR
• Patient Weight: 69