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

Model Number	BXA077902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The following information was reported to gore: on (b)(6) 2021 a patient underwent endovascular treatment in the tambe clinical trial.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized as a branch vessel stent in the left renal artery.After the stent was deployed, it became occluded with thrombus.This occlusion was treated by means of thrombolysis and balloon angioplasty.The patient tolerated the procedure.
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.
Additional Manufacturer Narrative
Additional information: h.6.Results code 213: a review of the sterilization records indicated the lot met all pre-release specifications.Product investigation report conclusion the specific cause of this complaint could not be determined.Gore did not receive the explanted device and information regarding the device form and the procedure were not available.A product history review was completed, including device manufacturing, heparin coating, and sterilization processes, and the device lot met all pre-release specifications.The investigation confirms the complaint of occlusion but is unable to assign cause.There are potential process failure modes and reasonably foreseeable misuse(s) identified for which cause is possible, but no conclusion can be drawn on them because the device was not available for evaluation.

• 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: 11207709
• Report Number: 2017233-2021-01615
• Device Sequence Number: 14578360
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2021

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: 07/27/2023
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 08/25/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/24/2021; 08/25/2021
• 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 Age: 71 YR
• Patient Weight: 82