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

Catalog Number BXA095902F

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/26/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.This code is used to describe a celiac artery stent stenosis.Also was involved a bxa095902f/(b)(4) udi# (b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

On (b)(6) 2018, this patient underwent endovascular treatment for an aortic aneurysm of unknown maximum diameter.The patient is enrolled in the aaa 13-02 tambe ide study.It was reported that the procedure included implant of gore® viabahn® vbx balloon expandable endoprostheses in the sma.On (b)(6) 2021, a celiac artery stent stenosis was determined.Reportedly, it was related with the endovascular procedure.The gore® viabahn® vbx balloon expandable endoprosthesis was compressed.According to the physician, the celiac trunk compression was through the medial ligament.For the stent graft stenosis, an angioplasty with a gore® viabahn® vbx balloon expandable endoprosthesis (9x39mm) and a pre-ballooning with 8x20mm balloon were performed.The patient presented a good post-procedure condition and was submitted to an ecodoppler with contrast that showed complete resolution of the treated endoleak.The patient was discharged after 3rd day with a good clinical condition.

Manufacturer Narrative

H6: code 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.Also was involved a bxa095902f/17240440.Udi# (b)(4).The devices remain implanted and are not available for investigation.Code 4581- this code is used to describe a celiac artery stent stenosis.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to stenosis and device failure.

Manufacturer Narrative

Revised h6 investigation conclusion 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12965768
• MDR Text Key: 281993017
• Report Number: 2017233-2021-02603
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Catalogue Number: BXA095902F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 05/31/2022
• Supplement Dates FDA Received: 01/06/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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; Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White