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

Catalog Number BXA117902A

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: 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

Evaluation of technical success, efficacy, and safety of portomesenteric venous intervention following nontransplant hepatobiliary or pancreatic surgery.Purpose: to evaluate technical success, efficacy and safety of portomesenteric venous (pmv) intervention for pmv stenosis or occlusion following nontransplant hepatobiliary or pancreatic (hpb) surgery.Materials and methods: a retrospective review identified 42 patients (mean age 60 y) with pmv stenosis (n = 33; 79%) or occlusion (n = 9; 21%) who underwent attempted pmv intervention following hpb surgery between june 1, 2011, and april 1, 2018.Main outcomes were technical success, primary patency rates, and complications.Technical success was compared by venous pathology and primary pmv patency based on anticoagulation status after the procedure using fisher exact test.Rates of primary patency by stent group were estimated using kaplan-meier method.The article notes: occlusion that occurred which could potentially be associated with one or more of the eleven gore® viabahn® vbx balloon expandable endoprostheses devices implanted.

Manufacturer Narrative

Literature citation: vamshi k.Mugu, scott m.Thompson, chad j.Fleming, lavanya yohanathan, mark j.Truty, michael l.Kendrick, james c.Andrews, evaluation of technical success, efficacy, and safety of portomesenteric venous intervention following nontransplant hepatobiliary or pancreatic surgery, journal of vascular and interventional radiology, volume 31, issue 3, 2020, pages 416-424.E2, issn 1051-0443, https://doi.Org/10.1016/j.Jvir.2019.08.011.Patient information was obtained by patient demographics provided in the article.Additionally, the majority of patients with reported device occlusion underwent repeat device placement; therefore, this reintervention is listed as patient outcome for h6: health effect - impact code.

• 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: 11703917
• MDR Text Key: 246670087
• Report Number: 2017233-2021-01882
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA117902A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR