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

Model Number	PLA360400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) specifies: the safety and effectiveness of the gore excluder® aaa endoprosthesis have not been evaluated in the following patient populations: revision of previously placed stent grafts.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: endoleak, aneurysm enlargement.
Event or Problem Description
On (b)(6) 2016, this patient underwent an endovascular repair of a previous treatment for a type i endoleak (manufacturer unknown).The patient was implanted with a gore excluder aaa endoprosthesis aortic extender component.Reportedly, pre-treatment ultrasound showed that the maximum diameter of the aortic aneurysm/lesion was 134mm.On (b)(6) 2016, a persistent type i endoleak was identified.No treatment has been reported to gore.Reportedly, from (b)(6) 2016, the aneurysm decreased in size from 157mm to 154.7mm.On (b)(6) 2019, it was confirmed a persistent type i endoleak.There was no aneurysm enlargement and no reintervention reported.Reportedly, the physician confirmed that the patient had only one treatment for a type i endoleak in 2016.Reportedly, the follow-up on (b)(6) 2020, showed that the maximum diameter of the aortic aneurysm/lesion was 215mm.Reportedly, there was no type i endoleak noticed.According to the physician, the patient had a combination of a type ii or type iii endoleak.Reportedly, the aneurysm enlargement was not attributed to the type i found on (b)(6) 2016.According to the physician the aneurysm enlargement was likely due to the type ii endoleak.It was reported that on an unknown date between (b)(6) 2016 and (b)(6) 2021, the patient had an additional procedure.Several attempts were made to get the additional information from the physician/site, however, the information was not provided.On (b)(6) 2022, it was reported that the patient underwent reintervention on (b)(6) 2020, for treatment of the proximal type i endoleak and an aortic extender component was implanted with coverage of the renal arteries; and the left external iliac artery was implanted with a covered stent.The patient tolerated the procedure.
Event or Problem Description
On (b)(6) 2020, the patient underwent reintervention for treatment of a proximal type i endoleak and aneurysm enlargement.Contrast arteriography was performed and revealed resolution of the area of concern.A gore® viabahn® vbx balloon expandable endoprosthesis was inserted and deployed without difficulty in the left external iliac artery.Contrast arteriography revealed an improvement in the appearance of the vessel.A pigtail catheter was then placed through the left-side sheath in order to allow for imaging of the visceral vessels.The right side access was challenging as well.I initially attempted to place a 37 valiant navion cuff in order to treat the type ia endoleak.Due to the calcification and tortuosity, this was not possible.Balloon angioplasty of the right external iliac artery was performed and 7,000 units of heparin were administered prior to placement of the viabahn.In addition, proglide devices had been placed in the right common femoral artery puncture site.A gore® viabahn® vbx balloon expandable endoprosthesis was then deployed very nicely in the right external iliac artery and post post dilated.A 20-french sheath was passed through the external iliac artery and into the previously placed endovascular repair and a 37 mm valiant navion piece was implanted with nice overlap into the previously placed endograft.An additional 37 mm x 59 mm valiant navion device was then implanted at the level of the superior mesenteric artery with intentional coverage of the renal arteries.This entire area was then treated with a reliant balloon.A completion arteriogram revealed patency of the celiac artery and superior mesenteric artery.In addition, there was resolution of the type ia endoleak.The patient tolerated the procedure in stable condition.The patient¿s type 1 endoleak and intentional coverage of the renal arteries was due to the patient¿s renal disease.The amount of aneurysm enlargement was not known.On (b)(6) 2021, the patient expired.The patient¿s death certificate lists the cause of death to be chronic kidney disease.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: hypercholesterolemia, hypertension, renal insufficiency, prior vascular intervention: aaa endovascular repair.

• Brand Name: GORE® EXCLUDER®AAA ENDOPROSTHESIS
• Common Device Name: 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14346830
• Report Number: 2953161-2022-01135
• Device Sequence Number: 14757555
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/11/2022
• Date Device Manufactured: 03/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White