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

Catalog Number	BXA063902A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Occlusion (1984); Perforation of Vessels (2135)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.The explanted device was discarded at user facility.Therefore, direct product analysis was not possible.A medwatch report (number 2017233-2018-00747) was submitted separately for device lot number 18694367; udi number (b)(4).Instructions for use (ifu) for gore® viabahn® vbx balloon expandable endoprosthesis intended use / indications, state the gore® viabahn® vbx balloon expandable endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, a patient presented for treatment of an aneurysmal celiac artery.Two gore® viabahn® vbx balloon expandable endoprostheses were implanted to cover the area from the celiac artery origin to the bifurcation.First, the splenic artery was coiled, then a vbx device was deployed.The second vbx devices was overlapped with the first one, devices were ballooned properly.As reported, the case went well and the patient tolerated the procedure.On (b)(6) 2018, it was found the vbx devices had occluded.The patient was taken to surgery for open repair.A tear was also found near the origin of the celiac artery.A bypass was created and the vbx devices were explanted and discarded.The patient was reported to be recovering well following the intervention.
Additional Manufacturer Narrative
Conclusion codes were updated.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8139353
• Report Number: 2017233-2018-00746
• Device Sequence Number: 13930698
• Product Code: NIO
• UDI-Device Identifier: 00733132637195
• UDI-Public: 00733132637195
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 03/25/2021
• Device Catalogue Number: BXA063902A
• Device Lot Number: 18125036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 03/16/2019
• 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: Required Intervention
• Patient Age: 58 YR