MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU282815

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): patient medications include but are not limited to: ensure, metoprolol tartrate, bumetanide, warfarin, atorvastatin, escitalopram, levetiracetam, acetaminophen, aspirin, tgu454510/16453866, tgu373715/14227726.Udi: (b)(4).Images were made available to gore but did not provide for any evaluation of the event.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.The instructions for use (ifu) for the gore® tag® thoracic endoprosthesis states: failure to properly follow the instructions, warnings, and precautions may lead to serious surgical consequences, injury to the patient or death.

Event Description

On (b)(6) 2017 a patient was undergoing treatment of a thoraco-abdominal aneurysm with gore® tag® thoracic endoprostheses, gore® viabahn® endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses.A modified aortic implant with multiple branch endoprostheses using aortic and peripheral devices was utilized in the procedure.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.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6832297
• MDR Text Key: 84076031
• Report Number: 2017233-2017-00437
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: TGU282815
• Device Lot Number: 13160924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 50