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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

As the devices were not returned, no evaluation of the devices could be performed.

Event Description

The following abstract was reviewed: "endovascular management of celiac artery pseudoaneurysm after ballistic injury" kevin treto et al.Abstracts accepted for presentation during the florida vascular society¿s 32nd annual scientific sessions meeting accepted november 2019.Objective: celiac artery aneurysms (caas) are a rare pathology of the splanchnic vessels, degenerative atherosclerosis being the etiology in the majority of cases.Traumatic pseudoaneurysms of the celiac artery are a subset of this pathology with scarce documented case reports in the literature.Trauma to the celiac artery can be secondary to endovascular intervention, blunt, or penetrating injury.Although not a true aneurysm, pseudoaneurysms warrant the same intervention to eliminate the risk of rupture.We present a case of a traumatic bilobed celiac artery pseudoaneurysm secondary to a ballistic injury.Case report: a (b)(6) male presented to the emergency department after sustaining multiple gunshot wounds to the chest, abdomen, and right upper extremity.It was reported three gore® viabahn® vbx balloon expandable endoprostheses were implanted in the patients celiac artery to treat a pseduanerusym.Follow-up imaging did reveal thrombosis of his celiac artery with hepatic and splenic artery reconstitution and patent superior and inferior mesenteric arteries.

Manufacturer Narrative

As it is unknown which device(s) may have contributed to the thrombosis, two additional gore® viabahn® vbx balloon expandable endoprosthesis devices have been included in this report: (lot number unknown and udi unknown) and (lot number unknown and udi unknown).

Manufacturer Narrative

Corrected h6 method code: 4114.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9886470
• MDR Text Key: 194119416
• Report Number: 2017233-2020-00215
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR