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

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Citation: mugu vk, thompson sm, fleming cj, yohanathan l, truty mj, kendrick ml, et al.Evaluation of technical success, efficacy, and safety of portomesenteric venous intervention following nontransplant hepatobiliary or pancreatic surgery.J vasc interv radiol.2020;31(3):416-24.E2.Published online.Https://doi.Org/10.1016/j.Jvir.2019.08.011.Patient demographics from the article: mean age is 60.1 years; 21 males and 21 females.The gore® viabahn® vbx balloon expandable endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.The article reports stents used in the main portal vein, portal vein, and superior mesenteric vein.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

This information was received through literature article "evaluation of technical success, efficacy, and safety of portomesenteric venous intervention following nontransplant hepatobiliary or pancreatic surgery" published in the journal of vascular and interventional radiology, 22 jan 2020.The article is a retrospective review of 42 patients with portomesenteric venous (pmv) complications who underwent attempted pmv venoplasty and/or stent placement following nontransplant hepatobiliary or pancreatic surgery between june 1, 2011, and april 1, 2018.Choice of stent type (uncovered, covered, or combination of both) was at the discretion of the performing interventional radiologist based on anatomic and venous pathology considerations.Stents included protege gps (21 stents used), protege everflex (1 stent used), visi-pro (12 stents used) [all medtronic, minneapolis, mn], gore viabahn (1 stent used), viabahn vbx (11 stents used), viatorr (1 stent used) [all w.L.Gore & associates, flagstaff, az], and icast (1 stent used) [atrium medical, hudson, nh].Mean imaging follow-up was 8.6 months +/- 8.8.During imaging surveillance, 9 patients had loss of primary patency owing to in-stent stenosis (n=3), non-occlusive thrombus (n=3), or occlusive thrombosis (n=3).Five patients underwent repeat stent placement, 2 patients received antiocoagulation therapy only, and 2 patients underwent no medical intervention.It is unknown if the reported loss of primary patency was attributable to any of the gore devices.

Manufacturer Narrative

Corrected section d.Suspect medical device - product code and common device name.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10518685
• MDR Text Key: 206489058
• Report Number: 2017233-2020-01248
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR