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

Model Number	BXA065902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
B.5.Updated.D.1./2.Updated.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10891911
• Report Number: 2017233-2020-01483
• Device Sequence Number: 3164884
• Product Code: PRL
• UDI-Device Identifier: 00733132637218
• UDI-Public: 00733132637218
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: BXA065902A
• Device Catalogue Number: BXA065902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 01/13/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/21/2021; 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 77