MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/30/2018

Event Type  Injury  

Event Description

Within the article ¿results of hybrid procedures for treatment of aortoiliac trans-atlantic inter-society consensus ii d lesions with self-expanding covered heparin-bonded stent grafts¿, published by christian uhr et al, presented in the journal of cardiovascular surgery, manuscript accepted on january 30, 2018, the article result indicates the following: the purpose of this study was to examine the results of hybrid procedures with the use of a self-expanding covered heparin-bonded stent graft (viabahn) in patients with extensive aorto-iliac lesions who were not considered to be suitable for open aorto-iliac surgery.All patients who received a hybrid procedure in combination with a viabahn stent in the clinic to treat aortoiliac lesions between october 2011 and april 2017 were included in this retrospective analysis.Study endpoints were primary patency, amputation free survival (afs) and major adverse limb event (male) free survival after 2 years.Major amputation rate was 4.3%.Due to extensive necrosis of the leg and re-perfusion syndrome the clinic performed an above knee amputation within 24 hours after revascularization in this case.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8173030
• MDR Text Key: 130616888
• Report Number: 2017233-2018-00752
• 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
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR