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

Catalog Number	BXA083901A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/04/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore by the doctor: right cia cto crossed, 8mm vbx (#18541468, bxa083901a) deployed without post-dilation.Femoro-femoral bypass graft placed (#6061060, ht064050a).Before leaving or the films were reviewed and simultaneously, the patient became hypotensive; it was noticed that on the completion aorto-iliac angiogram, there was a blush from the proximal edge of the stent.A second 8mm vbx (#18832099, bxa082801a) was placed with proximal overlap extending into the distal aorta and covering the area of extravasation.This second vbx was post-dilated with a 10x2 balloon.The next completion aorto-iliac angiogram showed no further extravasation and the hypotension resolved promptly.The patient remained stable in the operating room and was transferred to the icu for observation.Shortly after arrival to the icu, the patient again became hypotensive and arrested.The abdomen was noted to be distended and rigid.Resuscitation and cpr were unsuccessful and she was pronounced dead.
Additional Manufacturer Narrative
Additional manufacturer narrative: gore® viabahn® vbx balloon expandable endoprosthesis (#18832099 bxa082801a) was implanted to treat the extravasation caused by the implantation of the first gore® viabahn® vbx balloon expandable endoprosthesis (#18541468 bxa083901a).Additional information about this event could not be obtained.As a result, no further investigation is possible.

• 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: 8302196
• Report Number: 2017233-2019-00062
• Device Sequence Number: 986417
• Product Code: NIO
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• 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): 03/07/2019

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: 06/29/2021
• Device Catalogue Number: BXA083901A
• Device Lot Number: 18541468
• 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: 02/04/2019
• Supplement Report FDA Received Date: 02/15/2019; 03/07/2019
• 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: Death
• Patient Age: 66 YR