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

Catalog Number BXA103901J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2019

Event Type  Injury  

Event Description

The following publication was reviewed: title: a case of type ib endoleak resolved by coil embolization after viabahn vbx implantation for traumatic dissection of the right brachiocephalic artery source: official journal of the japanese society for vascular surgery 2020: 29(suppl.) p48-5 case report: on an unknown date in october 2018, a (b)(6) man was transported to the hospital with multiple traumatic injuries after an accident.Ct examination showed various fractures, intra-abdominal hemorrhage, liver injury, mesenteric injury, mediastinal hematoma, and dissection of the right brachiocephalic artery.For the traumatic dissection of the right brachiocephalic artery, gore® viabahn® vbx balloon expandable endoprosthesis (10.0/39) was implanted.A contrast-enhanced ct scan during follow-up revealed the vbx device originally implanted in october 2018 had a type ib endoleak, so in november 2019 the patient was admitted to the hospital for reintervention.A type ib endoleak was confirmed at 1 cm distal to the right carotid artery and right subclavian artery bifurcation.A viabahn® vbx (8.0/39) was advanced from the right femoral artery and implanted to the distal side.Since the type ib endoleak still remained, a catheter, a 0.014 guidewire, and a microcatheter were advanced into the dissection cavity / false lumen from the right radial artery, and coil embolization was successfully performed to resolve the remaining endoleak.

Manufacturer Narrative

Implant date entered as (b)(6) 2018 to represent unknown implantation date in (b)(6) 2018.(b)(4).Gore requested further information regarding exact dates, patient information, and device serial number but no further information was made available, therefore this investigation is considered complete.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Updated attachments.Attached the following publication that was reviewed, " a case of type ib endoleak resolved by coil embolization after viabahn vbx implantation for traumatic dissection of the right brachiocephalic artery" source: official journal of the japanese society for vascular surgery 2020: 29(suppl.) p48-5.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13453686
• MDR Text Key: 286504544
• Report Number: 2017233-2022-02714
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA103901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male