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

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

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).

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 a case of a (b)(6)-year-old man was reported, who was treated by branched endovascular repair for a thoracoabdominal aneurysm.A viabahn® vbx balloon expandable endoprostheses were implanted as a bridging stent grafts to the celiac trunk, the superior mesenteric artery and the right renal artery.In a control computed tomography angiography (cta) scan, 218 days after the index procedure, a stenosis at the distal edge of the viabahn® vbx balloon expandable endoprostheses was detected in the celiac trunk, superior mesenteric artery, and right renal artery.All stenoses were clinically inapparent.Reportedly, all stenoses were treated with a gore® viabahn® endoprosthesis with propaten bioactive surface during a reintervention.In the article it was stated, that they hypothesized, that these stenoses might have been caused by intimal hyperplasia due to overdilation of the target vessel during implantation.Because the diameter of the viabahn® vbx balloon expandable endoprosthesis is more adaptable, their common practice is to inflate the viabahn® vbx balloon expandable endoprostheses only to submaximal diameters at the distal edge.For this approach a sufficient landing zone is absolutely necessary to prevent from type ic endoleaks.

Manufacturer Narrative

The following literature articles were 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.Multiple events are related to these literatures: 44246 (mfr report#: 2017233-2020-00162); 44248 (mfr report#: 2017233-2020-00163); 44267 (mfr report#: 2017233-2020-00164); 44268 (mfr reports#: 2017233-2020-00167; #: 2017233-2020-00166; #: 2017233-2020-00165); 44270 (mfr report#: 2017233-2020-00168).B3: updated date of event with the date the literature was accepted.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: 9803578
• MDR Text Key: 196392424
• Report Number: 2017233-2020-00167
• 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
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2020
• 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: 65 YR