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

Model Number BXA065902A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2019 a patient underwent endovascular treatment as a subject in the aaa 17-01 tambe clinical trial.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized in the left renal artery.On (b)(6) 2020, a type ic endoleak involving the vbx device in the left renal artery was discovered and treated by means of another vbx device.The endoleak was resolved.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6), 2019 a patient underwent endovascular treatment as a subject in the aaa 17-01 tambe clinical trial.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized in the left renal artery.On (b)(6), 2019 a balloon was placed into the celiac and sma were inflated at the same time in kissing fashion.On (b)(6), 2020, a type ic endoleak involving the vbx device in the left renal artery at the side branch attachment was discovered and treated by means of another vbx device.There was no kink or undersizing of the device.There was no insufficiency in the device seal.The endoleak was resolved.

Manufacturer Narrative

B.5.Updated.D.1./2.Updated.

• 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
• MDR Report Key: 10891911
• MDR Text Key: 217975633
• Report Number: 2017233-2020-01483
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637218
• UDI-Public: 00733132637218
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: BXA065902A
• Device Catalogue Number: BXA065902A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 77