MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number PAC101002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The gore® viabahn® endoprosthesis instructions for use states, special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Literature citation: massiere b et al.2016 "ten-year experience with management of aortoiliac aneurysms using retrograde endovascular internal iliac artery preservation" ann vasc surg 2016; 35: 163-167.

Event Description

In a literature article titled "ten-year experience with management of aortoiliac aneurysms using retrograde endovascular internal iliac artery preservation" it states gore® viabahn® endoprostheses were utilized in conjunction with apollo aortomonoiliac devices on the contralateral side, positioned from the external iliac artery into the internal iliac artery as a bridging stent and femorofemoral bypass.Type ib endoleak associated with the viabahn was diagnosed in 1 patient.Subsequent evaluation revealed that the viabahn was undersized for external iliac artery and another procedure was performed to implant a larger viabahn distally.A viabahn occlusion was diagnosed in 1 patient, at on month.This patient had a 4-mm iia and a 5-mm viabahn implanted.This patient did not exhibit symptoms of pelvic ischemia.This event addresses the type ib endoleak.

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

Updated model # and name, address.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6985720
• MDR Text Key: 90507815
• Report Number: 2017233-2017-00565
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

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: 02/28/2013
• Device Catalogue Number: PAC101002
• Device Lot Number: 7627119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR