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

Catalog Number RLT231212

Device Problems Off-Label Use (1494); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Low Blood Pressure/ Hypotension (1914); Shock (2072); Vomiting (2144); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

H6: code c20: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa).The gore® excluder® aaa endoprosthesis is contraindicated in: patients with a systemic infection who may be at increased risk of endovascular graft infection.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: patients with active systemic infections.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular techniques.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to occlusion of device or native vessel and death.Please note that the article is attached to the report.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

On april 3, 2023, the article "aortoduodenal fistula from duodenal stenting for malignant gastric obstruction " published on august 24, 2022 by eleni bacopanos, shirley jansen and joe hockley was received.In this article the aortoduodenal fistula (adf) was investigated following duodenal stent insertion for gastric outflow obstruction secondary to metastatic adenocarcinoma.In this case, a 51 year old man presented with hematemesis and collapse, seven months after the insertion of a duodenal wallflex 120x22 mm stent (boston scientific marlborough, ma, usa) for gastric outlet obstruction for metastatic colorectal adenocarcinoma diagnosed five years earlier and previous chemoradiotherapy.On presentation, the patient was in shock (blood pressure 95/60 mmhg), with a distended abdomen and hemoglobin of 7.2 g/l, despite having received three units of packed red blood cells (prbc).Intravenous (iv) fluid resuscitation with prophylactic antibiotics was administered.Triphasic computed tomography angiogram identified locules of gas within the retroperitoneal para-aortic soft tissue, in keeping with a fistulous communication with the duodenum; cta did not identify active bleeding.The patient was transferred to the interventional endovascular suite for emergency evar.Bilateral percutaneous femoral access was obtained.Angiography identified aortic narrowing with thrombus at the level of the duodenal stent without pseudoaneurysm.An occlusion balloon was placed within the thoracic aorta for 10 minutes to reduce hypotension.A 23x12x12 gore bifurcate stent graft (wl gore, flagstaff, az, usa) with an iliac artery limb extension (16x12x10) on the left was implanted.Day 1 post-operatively the right iliac limb occluded resulting in acute limb ischemia, probably due to limb compression within a narrow aorta.Graft thrombectomy, four compartment fasciotomy, and bilateral balloon expandable stents were placed in the contralateral gate and right iliac limb.Post-operative issues included pain, physical deconditioning, and concerns of stent graft infection due to ongoing elevated inflammatory markers, treated empirically with piperacilline-tazobactam.The patient was discharged after five weeks to rehabilitation with lifelong oral moxifloxacin and died at an external facility.His cause of death is not known to the authors; his overall survival was two years.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16728933
• MDR Text Key: 313191112
• Report Number: 2017233-2023-03853
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

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 Catalogue Number: RLT231212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male