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

Device Problems Partial Blockage (1065); Complete Blockage (1094); Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

The following abstract was reviewed: "performance of viabahn balloon-expandable stent compared with self-expanding covered stents for fenestrated-branched endovascular aortic repair" (fernando motta, m.D.; frederico e.Parodi, m.D.; jason r.Crowner, m.D.; luigi pascarella, m.D.; katharine l.Mcginigle, m.D.; william a.Marston, m.D.; melina r.Kibbe, m.D.; mark a.Farber, m.D.; savs22; journal of vascular surgery, january 2020, volume 71, number 1; page e28 & e29.The objective of the physician sponsored investigational device exemption trial was to compare the performance between gore® viabahn® vbx balloon expandable endoprosthesis and self-expanding covered stents (gore® viabahn® endoprosthesis & fluency¿ plus endovascular stent graft) (ses) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms.The median patient age was 71 with 70% male.Total number of vessels incorporated to repair was 977 of which 179 were branch vessels (54 celiac artery, 56 superior mesenteric artery, 38 right renal artery, and 31 left renal artery).Primary patency rates at 24 months for vbx was 98.1%, and,98.6 for ses.Freedom from endoleaks (vbx - 97.3, ses 98.6%), freedom from secondary intervention (vbx - 91.5%, ses 95%), and freedom branch instability (vbx - 95.5%, ses 97.3%).The abstract reports the vbx demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death.

Event Description

Reviewed was article titled, performance of viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.Authors: fernando motta, md, f.Ezequiel parodi, md, martyn knowles, md, mba, jason r.Crowner, md, luigi pascarella, md, katharine l.Mcginigle, md, mph, william a.Marston, md, melina r.Kibbe, md, elad ohana, rt(r)(ci)(vi), and mark a.Farber, md, chapel hill, nc.Society for vascular surgery, vol 73 no.2.Accepted may 14, 2020.The study compares the performance between gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and self-expanding covered stents ([ses] - gore® viabahn® endoprosthesis and fluency¿ plus endovascular stent graft) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms.The study includes 62 patients and 177 branches that were incorporated into the fenestrated-branched endovascular aneurysm repairs between july 2012 and june 2019.There was no branch-related rupture or mortality.Primary patency at 24 months (vbx, 98.1%; ses, 98.6%), freedom from endoleak (vbx, 95.6%; ses, 98.6%;), freedom from secondary intervention (vbx, 94.7%; ses, 98.1%), and freedom from branch instability (vbx, 95.6%; ses) were similar between groups.The median age of the patients treated with a branch was 68.5 years (63-75 years); 66% were male.Branch-related outcomes state at follow-up, two occlusions occurred at the celiac artery (ca), one was with a gore® viabahn® endoprosthesis and the other was a non-gore device.It was reported the occlusions were probably secondary to median arcuate ligament compression.The patients did not need reintervention because the patients were asymptomatic.

Manufacturer Narrative

Article: performance of viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.Society for vascular surgery.Https://doi.Org/10.1016/j.Jvs.2020.05.028.Combination product: cbas® heparin surface manufacturer/compounder: w.L.Gore & associates, inc.Lot number: unk cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.As a cross reference, mfr report #2017233-2020-00116 is associated with this same article.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9740626
• MDR Text Key: 188246930
• Report Number: 2017233-2020-00118
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

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: 02/21/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2020; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR