MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number RLT231414

Device Problems Collapse (1099); Material Invagination (1336); Patient-Device Incompatibility (2682)

Patient Problems Occlusion (1984); Pain (1994); Thrombus (2101)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 the patient underwent endovascular repair of a 4.7cm right common iliac artery aneurysm using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.A small distal aortic aneurysm was also reportedly present, but treatment was focused on the iliac artery aneurysm.The gore® excluder® iliac branch devices were placed on the patient's right side.It was reported that, upon completion of the procedure, the trunk-ipsilateral leg component in the patient's infrarenal abdominal aorta did not have full circumferential wall apposition proximally (a bird beak was present) due to angulation of the patient's aorta.The angle of the patient's aorta is reportedly unavailable.On (b)(6) 2020 the patient presented with bilateral leg pain.One hour after the patient presented with the reported leg pain, a ct was performed.It was reported that the proximal main body of the trunk-ipsilateral leg component had collapsed and was thrombosed.Compression was present on the trunk main body of the device.Reportedly it is unknown if any blood flow was present through the device.No thrombus or occlusion was reportedly present in the contralateral leg component, or the gore® excluder® iliac branch endoprostheses.The suspected reason for collapse and thrombosis of the trunk-ipsilateral leg component was reportedly due to the pre-existing bird beak.An axillobifemoral bypass was performed to treat the collapsed device.The patient reportedly tolerated the procedure.

Manufacturer Narrative

H.6.Results code 2 updated.H.6.Results code 2: code 213 - the engineering evaluation showed the following: the device instructions for use (ifu) states that the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease, and who have appropriate anatomy as described below: adequate iliac / femoral access.Infrarenal aortic neck treatment diameter range of 19 ¿ 32 mm and a minimum aortic neck length of 15 mm.Proximal aortic neck angulation = 60°.Iliac artery treatment diameter range of 8 ¿ 25 mm and iliac distal vessel seal zone.Length of at least 10 mm.An imaging evaluation was performed by gore and concluded: the imaging provided for review is a non-contrast ct.Therefore, the imaging evaluation is very limited.Axial image from ct dated (b)(6) 2020 illustrates an invagination of the proximal aspect of the trunk ipsilateral component.Without a physical sample to evaluate, the physician¿s observation that upon completion of the procedure, the trunk-ipsilateral leg component in the patient's infrarenal abdominal aorta did not have full circumferential wall apposition proximally, was confirmed.Also, the physician¿s comment that, later on, the proximal main body of the trunk-ipsilateral leg component had collapsed and was thrombosed was confirmed.It was not possible to confirm the physician¿s observation that blood flow was present or not through the device.The reported suspected reason for collapse and thrombosis of the trunk-ipsilateral leg component due to the pre-existing bird beak could not be determined.The likely cause for the reported occlusions/compressions could not be determined with the available information.H.6.Conclusions code 1 updated.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9633885
• MDR Text Key: 188869444
• Report Number: 3007284313-2020-00016
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: 04/11/2022
• Device Model Number: RLT231414
• Device Catalogue Number: RLT231414
• Device Lot Number: 20470457
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 80