MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Patient age: mean age 71 years.Patient gender: vast majority is male.Date the events occurred are unknown, so the date the article was accepted was used as date of event.Date of implant is unknown, so the date the study started was used as the date of implant.(b)(4).The information available relating to the reported event is not sufficient to identify the device, because the lot numbers have not been provided.The lot numbers were requested.The devices remain implanted, so an engineering evaluation could not be performed.Dicom images of the event have been requested, but were not provided to gore.

Event Description

The following literature article was reviewed: "outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair" giovanni federico torsello et al.Journal of vascular surgery article in press submitted mar 25, 2019; accepted oct 24, 2019; available online jan 19, 2020 https://doi.Org/10.1016/j.Jvs.2019.10.089 presented in part at the 2019 leipzig interventional course (linc 2019), leipzig, germany, january 22-25, 2019.The purpose of this single-center, non-randomized study was to evaluate the clinical performance of the well-known advanta/icast v12 (getinge maquet) and the new gore® viabahn® vbx balloon expandable endoprosthesis in complex fenestrated and branched endovascular aortic aneurysm repair in combination with off-the-shelf branched (t-branch; cook medical) and custom-made fenestrated and branched stent grafts (zenith fenestrated or branched; cook medical).Between december 2017 and july 2018, there were 50 patients (40 male; mean age, 71 years) included.Retrospective analysis of prospectively collected data was performed.The following numbers of stent grafts of various manufacturers were implanted in total 198 side branches: 145 viabahn® vbx balloon expandable endoprosthesis, 57 advanta v12, 29 gore® viabahn® endoprosthesis with propaten bioactive surface, 28 bare-metal stents (protégé everflex, medtronic; smart flex, cordis).The viabahn® vbx balloon expandable endoprosthesis was mainly implanted for bridging long distances and where flexibility was required.The bare-metal stents were implanted as an additional device for relining in case the bridging device did not reach the desired position in the target vessel or did not conform to the target vessel shape.The following numbers of side branches were exclusively sealed with viabahn® vbx balloon expandable endoprostheses: 27 celiac trunk, 25 superior mesenteric artery, 74 renal arteries.Eight additional branches were treated with one of the above mentioned devices: 1 inferior mesenteric artery, 1 isolated common hepatic artery, 1 accessory left renal artery, 5 accessory right renal arteries.Completion angiography showed primary patency of all target vessels.Within the article it was reported, that two viabahn® vbx balloon expandable endoprosthesis related reinterventions were performed due to a type ic endoleak.These endoleaks were corrected by implantation of another viabahn® vbx balloon expandable endoprosthesis in a second session.The reason for endoleak was insufficient overlapping.In the article it was stated, that one of the key learnings of their initial clinical experience is that the landing zone in the target vessel needs to be as long as possible.Trying to preserve polar arteries in early renal artery branching might lead to increased type ic endoleak risk.

Manufacturer Narrative

The following literature article was reviewed: "outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair".Giovanni federico torsello et al.Journal of vascular surgery: article in press: submitted mar 25, 2019; accepted oct 24, 2019; available online jan 19, 2020.Https://doi.Org/10.1016/j.Jvs.2019.10.089.Presented in part at the 2019 leipzig interventional course (linc 2019), leipzig, germany, (b)(6) 2019.Multiple events are related to this literature: 44246 (mfr report # 2017233-2020-00162); 44248 (mfr report # 2017233-2020-00163); 44267 (mfr report # 2017233-2020-00164); 44268 (mfr report # 2017233-2020-00167); 44270 (mfr report # 2017233-2020-00168) - attachment: [44246_literature article_07feb20.Pdf].

Manufacturer Narrative

Updated list of events are related to this literature: (b)(4),(mfr report # 2017233-2020-00162).(b)(4),(mfr report # 2017233-2020-00163).(b)(4),(mfr report # 2017233-2020-00164).(b)(4), (mfr reports # 2017233-2020-00167; # 2017233-2020-00166; # 2017233-2020-00165).(b)(4), (mfr report # 2017233-2020-00168).

Event Description

The following literature article was reviewed: "outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair" giovanni federico torsello et al.Journal of vascular surgery article in press submitted mar 25, 2019; accepted oct 24, 2019; available online jan 19, 2020.Https://doi.Org/10.1016/j.Jvs.2019.10.089.Presented in part at the 2019 leipzig interventional course (linc 2019), (b)(6), germany, january 22-25, 2019.The purpose of this single-center, non-randomized study was to evaluate the clinical performance of the well-known advanta/icast v12 (getinge maquet) and the new gore® viabahn® vbx balloon expandable endoprosthesis in complex fenestrated and branched endovascular aortic aneurysm repair in combination with off-the-shelf branched (t-branch; cook medical) and custom-made fenestrated and branched stent grafts (zenith fenestrated or branched; cook medical).Between december 2017 and july 2018, there were 50 patients (40 male; mean age, 71 years) included.Retrospective analysis of prospectively collected data was performed.The following numbers of stent grafts of various manufacturers were implanted in a total 198 side branches: - 145 viabahn® vbx balloon expandable endoprosthesis - 57 advanta v12 - 29 gore® viabahn® endoprosthesis with propaten bioactive surface - 28 bare-metal stents (protégé everflex, medtronic; smart flex, cordis) the viabahn® vbx balloon expandable endoprosthesis was mainly implanted for bridging long distances and where flexibility was required.The bare-metal stents were implanted as an additional device for relining in case the bridging device did not reach the desired position in the target vessel or did not conform to the target vessel shape.The following numbers of side branches were exclusively sealed with viabahn® vbx balloon expandable endoprostheses: - 27 celiac trunk - 25 superior mesenteric artery - 74 renal arteries eight additional branches were treated with one of the above mentioned devices: - 1 inferior mesenteric artery - 1 isolated common hepatic artery, - 1 accessory left renal artery - 5 accessory right renal arteries completion angiography showed primary patency of all target vessels.Within the article it was reported, that two viabahn® vbx balloon expandable endoprosthesis related reinterventions were performed due to a type ic endoleak.These endoleaks were corrected by implantation of another viabahn® vbx balloon expandable endoprosthesis in a second session.It was stated, that the reason for endoleak was insufficient overlapping (landing zone).In the article it was stated, that one of the key learnings of their initial clinical experience is that the landing zone in the target vessel needs to be as long as possible.Trying to preserve polar arteries in early renal artery branching might lead to increased type ic endoleak risk.

Manufacturer Narrative

B5: updated event description.D6: the date of implant remains unknown.So this field was cleared.H6-code 3221: the requests to the author remain unanswered.The lot numbers remain unknown.Without additional information, gore was unable to do further investigation of this event.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9802323
• MDR Text Key: 193302135
• Report Number: 2017233-2020-00162
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR