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

Catalog Number	BXA085901A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medical devices: gore® dryseal flex introducer sheath (will be reported separately); gore® viabahn® vbx balloon expandable endoprosthesis (lot #18208255; udi # (b)(4).Both gore® viabahn® vbx balloon expandable endoprostheses were implanted in same area.(b)(4).A review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.The devices remain implanted.Therefore, direct product analysis was not possible.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, a patient presented with a thoracic aortic aneurysm and two conformable gore® tag® thoracic endoprostheses were implanted with no issues.While retracting a 24fr gore® dryseal flex introducer sheath the right common femoral artery was perforated.The patient became unstable due to blood pressure drop.A coda balloon was advanced to occlude the artery and a buddy wire was utilized to deploy two gore® viabahn® vbx balloon expandable endoprostheses in order to cover the perforated artery.The physician noticed under angiography the buddy wire had gone through the false lumen and the gore® viabahn® vbx balloon expandable endoprostheses were implanted in the false lumen.Attempts were made to gain access from the left common femoral artery.The plan was to crush the gore® viabahn® vbx balloon expandable endoprostheses in order to re-open the true lumen.However, the guidewire could not be advanced beyond the gore® viabahn® vbx balloon expandable endoprostheses.The patient hemorrhaged during these attempts and approximately ten units of blood were administered.The physician was unable to gain access to the true lumen.The patient expired.

• 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: 7688301
• Report Number: 2017233-2018-00378
• Device Sequence Number: 1315787
• Product Code: NIO
• UDI-Device Identifier: 00733132637324
• UDI-Public: 00733132637324
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 05/07/2021
• Device Catalogue Number: BXA085901A
• Device Lot Number: 18208252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2018
• 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: 65 YR