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

Catalog Number BXA062902E

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.This complaint was initiated based on information received from a study alert.No items were available to directly evaluate product performance relative to the reported device failure mode.Moreover, the available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.The reported device occlusion represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

(b)(6) 2024: the following attached literature article was received from the clinical complaints team associate.Article: martínez-rodrigo jj, boukhoubza a, enguix dp, et al.Feasibility and outcomes of transjugular intrahepatic portosystemic shunts in infants.Pediatric radiology.2023;53(5):953.This is a single center non-comparative observational cohort study.The study included 10 infants who had tips performed before liver transplantation from (b)(6) 2018 to (b)(6) 2021.They were referred to the hospital performing the study for complications related to hepatic disease which included biliary atresia, familial intrahepatic cholestasis, or cryptogenic cirrhosis and were in the liver transplant program.The main criterion for the tips procedure was refractory ascites that had failed medical treatment and portal vein size reduction on serial ultrasound [us] follow up.Out of the 10 patients, patient #6 and patient #9, both with the same diagnosis of biliary atresia received gore® viabahn stents.Patient #6 received two stents, one self-expandable stent [precise, cordis] and one covered balloon expandable [gore® viabahn® vbx balloon expandable endoprosthesis, 6x29mm].Patient #9 received four stents, two self-expandable stents [precise, cordis] and two covered balloon expandable [gore® viabahn® vbx balloon expandable endoprostheses, 5x15mm].Patient #6 had technical success and then had late stent thrombosis, 8 months after tips placement.The patient had reintervention and the stent was permeable at the last us, marked reduction of ascites and still on transplant list >23 weeks.Patient #9 had technical success and then had early stent thrombosis, 24-48 hours after tips placement.The patient had reintervention and the stent was permeable at the last us, marked reduction of ascites and still on transplant list >7 weeks.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: PRL / ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18756479
• MDR Text Key: 335933397
• Report Number: 2017233-2024-04646
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA062902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Required Intervention