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

Catalog Number BXA117902E

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The physician was requested to provide additional information to the database entries.His answers provided clarity about the event and his information is included in the event description.The delivery system of the device was discarded at the facility and the endoprosthesis remains implanted in the patient.Therefore an engineering evaluation could not be performed.A review of the manufacturing records indicated the device met pre-release specifications.

Event Description

On (b)(6) 2019, the patient underwent an endovascular treatment of an aneurysm of 15 cm in length of the right renal artery.Percutaneous access was gained via the femoral artery.To treat the aneurysm two gore® viabahn® vbx balloon expandable endoprostheses were intended to be used.It was stated, that the first viabahn® vbx endoprosthesis was advanced through an 8fr introducer sheath, navigated to its intended location and deployed as intended.Reportedly, the planned second viabahn® vbx endoprosthesis could not be advanced through the 8fr introducer sheath.When trying the advance the second viabahn® vbx endoprosthesis, the first viabahn® vbx endoprosthesis lost proximal sealing.Therefore the planned second viabahn® vbx endoprosthesis was withdrawn from the patient and other types of stent grafts were used to extend the viabahn® vbx endoprosthesis and to treat the endoleak.It was reported, that, however, the aneurysm was not fully excluded at the end of the procedure.It was assumed, that the sealing zone was too small because the stented length was only 15.6 cm.The physician opted for a wait-and-see strategy and completed the procedure without treating the endoleak.It was reported, that on (b)(6) 2019, new computed tomography angiography imaging clearly showed, that a disconnection between the implanted stents has led to a large endoleak type 3 in the right renal artery.It was stated, that on (b)(6) 2020, the endoleak was treated with a viabahn® vbx endoprosthesis (11 mm x 79 mm) during a re-intervention.Reportedly, the aneurysm was excluded.The patient is doing fine.

Manufacturer Narrative

B5: updated event description.H6-code 3190: updated device code.

Event Description

On (b)(6) 2019, the patient underwent an endovascular treatment of an aneurysm of 15 cm in length of the right renal artery.Percutaneous access was gained via the femoral artery.To treat the aneurysm two gore® viabahn® vbx balloon expandable endoprostheses were intended to be used.It was stated, that the first viabahn® vbx endoprosthesis was advanced through an 8fr introducer sheath, navigated to its intended location and deployed as intended.Reportedly, the planned second viabahn® vbx endoprosthesis could not be advanced through the 8fr introducer sheath.When trying the advance the second viabahn® vbx endoprosthesis, the first viabahn® vbx endoprosthesis lost proximal sealing.Therefore the planned second viabahn® vbx endoprosthesis was withdrawn from the patient and other types of stent grafts were used to extend the viabahn® vbx endoprosthesis and to treat the endoleak.It was reported, that, however, the aneurysm was not fully excluded at the end of the procedure.A type i endoleak remained.It was assumed, that the sealing zone was too small, because the stented length was only 15.6 cm.The physician opted for a wait-and-see strategy and completed the procedure without treating the endoleak.It was reported, that on june 28, 2019, new computed tomography angiography imaging clearly showed, that a disconnection between the implanted stents has led to a large endoleak type iii in the right renal artery.It was stated, that on july 23, 2020, the type iii endoleak was treated with a viabahn® vbx endoprosthesis (11 mm x 79 mm) during a re-intervention.Reportedly, the aneurysm was excluded.The patient is doing fine.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9772483
• MDR Text Key: 188725979
• Report Number: 2017233-2020-00135
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2021
• Device Catalogue Number: BXA117902E
• Device Lot Number: 20151697
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 92