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

Model Number	BXA062902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for aortic aneurysm repair.The doctor selected a cook fenestrated device for the aaa repair and a gore® viabahn® vbx balloon expandable endoprosthesis for the left renal fenestration.The cook device was placed with no issue.The gore® viabahn® vbx balloon expandable endoprosthesis was placed with no issue, and ballooned using an 8mm balloon, causing the device to foreshorten.The doctor observed that the device was in an acceptable position and completed the case.The patient presented the following day with an occluded gore® viabahn® vbx balloon expandable endoprosthesis.The doctor used tpn to break the clot up, a penumbra device to suction out the clot, and another gore® viabahn® vbx balloon expandable endoprosthesis to reline the previous vbx device.
Additional Manufacturer Narrative
Corrected data: h6.Results code 1.H6.Conclusions code 1.Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.
Additional Manufacturer Narrative
Additional manufacturer narrative: physician who reviewed the procedural films for the case reported that the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was not the cause of the occlusion.It appeared that the vbx device was placed too far into the renal artery with no communication to the aortic graft.

• 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: 9572218
• Report Number: 2017233-2020-00017
• Device Sequence Number: 10856232
• Product Code: NIO
• UDI-Device Identifier: 00733132637478
• UDI-Public: 00733132637478
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

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: 08/08/2022
• Device Model Number: BXA062902A
• Device Catalogue Number: BXA062902A
• Device Lot Number: 21300441
• 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; Not provided
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/18/2020; 03/02/2020
• 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: 75 YR