MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number RLT231214

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemic Shock (1917); Cardiogenic Shock (2262)

Event Date 01/26/2021

Event Type  Death  

Manufacturer Narrative

Patient medical history includes but is not limited to: liver cancer currently being treated with tace, aaa, alcohol dependence, hypertension, joint pain, left leg pain, liver lesion, left lobe, liver mass, pad.Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: rlt231214/18419655.Patient medications include but are not limited to: acetaminophen.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: death.

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment of a symptomatic abdominal aortic aneurysm with short distance claudication of both lower extremities and bilateral iliac artery occlusions; with complete occlusion of the right external iliac artery (rcia) and left common iliac artery (lcia).Post dissection of the bilateral cia¿s a gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) was advanced and deployed within the rcia and extended with a gore® viabahn® endoprosthesis with heparin bioactive surface down to the reia and inflated to 12mmhg.A 16 fr sheath was then advanced through the right iliac viabahn® system and a gore® excluder® trunk ipsilateral leg component featuring c3® delivery system was advanced and deployed just distal to the renal arteries.A second trunk ipsilateral leg component of the same size was then advanced and deployed to overlap the first one.Angioplasty of the entire system was performed all the way down to the common and external iliac¿s.Completion angiography demonstrated no endoleak and a widely patent graft system and a femoral to femoral artery bypass was performed.An angiograph was performed and showed two areas of sluggish flow within the bypass system and a gore® viabahn® endoprosthesis was implanted and dilated with a 8mm diameter balloon.Completion imaging was performed and demonstrated inline and brisk, pulsatile flow.The patient tolerated the procedure and was transferred to recovery in fair condition.On (b)(6) 2021, the patient expired from a likely combination of cardiogenic shock and hypovolemic shock.The patient suffered hepatocellular carcinoma and presume to develop hepatic coagulopathy on top of arteriosclerotic cardiovascular disease.

Manufacturer Narrative

H6: corrected code.

Manufacturer Narrative

H6: investigation conclusion updated to 50 - adverse event related to patient condition.

Manufacturer Narrative

B2: date of death added.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11382114
• MDR Text Key: 233691337
• Report Number: 3007284313-2021-01268
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2021

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: 07/30/2022
• Device Model Number: RLT231214
• Device Catalogue Number: RLT231214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 02/15/2021; 02/15/2021
• Supplement Dates FDA Received: 09/01/2021; 09/23/2021; 10/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 54