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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Article review: aortic arch endovascular branch and fenestrated repair: initial canadian experience with novel technology.Mark rockley, md et al.Journal of vascular surgery cases, innovations and techniques vol 9, issue 4.December 2023.Three medwatch reports will be submitted based on the attached article.Mfr report # 2017233-2024-04742 for patient 1.Patient age and gender were obtained from article.Patient id, weight, relevant medical history and medication information were requested from author.No response has been received.Device lot/serial number was requested, but not made available.Based on the article, the vbx device appears to remain implanted and lifelong antibiotics was prescribed to patient.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

Article: aortic arch endovascular branch and fenestrated repair: initial canadian experience with novel technology.Mark rockley, md et al.Journal of vascular surgery cases, innovations and techniques vol 9, issue 4.December 2023.This article included retrospective single-center consecutive case series of 11 predominantly male patients (average age of 72 years) undergoing aortic arch repair with fenestrated or branched endografts between december 2020 and march 2023.Ten procedures were elective, and one was emergent.Of the 16 branch stenting, seven gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were used in four patients.One gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device) was implanted in a patient.The additional eight devices include gore thoracic branch endoprosthesis (tbe) or excluder limb.Complete arch repair from zone 0 to 4 was performed in six cases; the remaining repairs landed proximally in zones 1 or 2.Seven repairs used a single retrograde facing inner branch (tbe), three used double antegrade inner branch (bolton relay; terumo interventional systems), and one emergent case used double in situ fenestrations.Seven repairs used an adjunctive extra-anatomic bypass to complete great vessel perfusion, two of which were created during a prior aortic repair.Inferior vena cava balloon inflow occlusion during deployment was used in all cases.No mortalities, transient or permanent spinal cord paralysis, myocardial infarction, dialysis dependence, venous thromboembolism, or bleeding requiring reintervention occurred.The median total hospital length of stay was 5 days and an average 7.8 months total follow-up.No patient developed branch vessel instability; no branches developed migration, occlusion, reintervention, arterial rupture, intraluminal thrombus, stenosis, or kinking.No patient in this series died.Patient 6 had a total aortic arch repair with a branched stent graft that was performed for dissection-related aortic degeneration, after remote acute type a dissection ascending aortic repair and subsequent descending aortic tevar.One month postop, patient 6 was diagnosed with a presumed aortic arch graft infection based on clinical and nuclear medicine findings, despite persistently negative blood cultures.The patient was treated with lifelong broad-spectrum antibiotics, with radiographic nuclear imaging improvement of infection after 7 months of antibiotics.

Manufacturer Narrative

Retraction of submitted mdr.After further evaluation, it was determined there was no reported allegations of product deficiency against the vbx devices.The complaint is not considered reportable as the reported infection is an aortic graft infection that appears to be related to the bolton relay aortic device (not the vbx devices).Additionally, no reintervention was performed to to treat/explant the vbx devices due to the reported infection.Therefore, this report is retracted.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18969637
• MDR Text Key: 338500964
• Report Number: 2017233-2024-04743
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male