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

Catalog Number BXA095902A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Occlusion (1984); Perforation (2001); Thrombus (2101); Ventricular Fibrillation (2130); Loss Of Pulse (2562)

Event Date 08/17/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Ncit patient concept code(s): c50470, c28554 ncit device concept code(s): c53269.Concomitant products: patient medications include but are not limited to: ensure, metoprolol tartrate , bumetanide, warfarin, atorvastatin, escitalopram, levetiracetam, acetaminophen, aspirin, instructions for use states: : as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.

Event Description

On (b)(6) 2017 a patient was undergoing treatment of a thoraco-abdominal aneurysm with gore® tag® thoracic endoprostheses, three gore® viabahn® endoprostheses and three gore® viabahn® vbx balloon expandable endoprostheses.A modified aortic implant was constructed with a main body made from gore® tag® thoracic endoprostheses with three created fenestrations to accommodate three viabahn devices.These viabahn devices were sewn into the graft and shortened.Additionally, three gore® viabahn® vbx balloon expandable endoprostheses were utilized to reinforce and extend the coverage in the treated vessels which were the right and left renals, and the superior mesenteric artery.In particular a bxa095902a device was utilized in the sma.The procedure was reported to have gone well.Postoperatively the patient was reported to have had a right hemispheric stroke, specifically shown in a ct as acute occlusion of the distal part of the left vertebral artery with thrombus.Also observed was intra-abdominal hemorrhage and abdominal cavity compartment syndrome.The patient was taken back to surgery and underwent a decompressive laparotomy with massive transfusion protocol included.This included levophed and vasopressin titration as well as 12 units of packed red blood cells, 9 units fresh frozen plasma and 1 unit platelets given via level one rapid infuser within the course of the procedure and transfer to recovery.The patient developed ventricular fibrillation, with no pulse.A code was called and cpr along with defibrillation were performed.The patient¿s family elected to stop the code measures and the patient expired.During the laparotomy a very large hematoma was seen within the transverse mesocolon which was thought to have been caused by a wire perforation of a branch of the superior mesenteric artery, with no active bleeding noted.Additionally there was no sign of a large vessel rupture because the completion angiogram taken following the implant procedure showed the covered stents to cover most of the aorta and visceral vessels.The viabahn devices, which were only utilized as ports from the main body graft are not implicated in this event.The viabahn devices were downstream and distal to the head vessels related to the stroke.Additionally all of the vbx devices were were downstream and distal to the head vessels related to the stroke.The injury to the colon is possibly potentially related to the bxa095902a device, and is reported.The remaining vbx devices are not implicated in the colon injury as they were used in the renal arteries, away from the sma.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6871429
• MDR Text Key: 88456242
• Report Number: 2017233-2017-00476
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/21/2019
• Device Catalogue Number: BXA095902A
• Device Lot Number: 16345838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 51