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

Model Number	RLT351418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: additional type ii endoleak, aneurysm enlargement, and interventions were reported under manufacturer report #2017233-2015-00863, #2017233-2019-00316, and #3007284313-2020-01157.Concomitant medical products and therapy dates: unavailable.
Event or Problem Description
On (b)(6) 2015, the patient underwent reintervention for an abdominal aortic aneurysm (aaa) with a maximum diameter measuring 65.0mm.Two gore® excluder® aaa endoprostheses were implanted to reline an unknown manufacturer¿s endovascular devices previously implanted on an unknown date in 2010 for treatment of a aaa.The patient tolerated the procedure and was discharged to home on (b)(6) 2015.The patient underwent intervention of type ii endoleaks and subsequent aneurysm enlargement on (b)(6) 2015, (b)(6) 2018, and (b)(6) 2019.At the time of the last intervention, the aneurysm measured 96.0mm.On (b)(6) 2019, an arteriogram was performed.On (b)(6) 2019, the aneurysm measured 92.0mm.On (b)(6) 2020, the aneurysm measured 91.0mm.On (b)(6) 2021, the aneurysm measured 99.0mm.On (b)(6) 2021 a type ii endoleak was identified.It was noted that, due to concerning growth of the aaa and to the endoleak being observed again at the level of the l3 vertebral body, surgery of selective branch vessels is scheduled for (b)(6) 2021.
Additional Manufacturer Narrative
H.6.Investigation findings: code 213 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.Furthermore, the ifu informs users of the risks associated with type ii endoleaks, and users are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Furthermore, the ifu states that the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, revision of previously placed stent grafts.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 22.
Additional Manufacturer Narrative
G.1.Manufacturing site name and address updated.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog#: plc161200 / serial#: (b)(6) / udi#: (b)(4).B.4.Additional event description added.D.10.Concomitant medical products and therapy dates: aspirin 81 mg tablet, atorvastatin (lipitor) 40 mg tablet, omeprazole (prilosec) 40 mg capsule, vardenafil (levitra) 10 mg tablet.H.6.Investigation findings: code 213 updated to code 3233 as additional product history record review will be performed.H.6.Investigation conclusions: code 22 updated to code 11.
Event or Problem Description
Additional information was provided that on (b)(6) 2021 the patient underwent explantation of the gore® excluder® aaa system and open juxtarenal aaa repair with aorto-bi-iliac graft placement due to the concerning aneurysm growth.The devices were removed using a combination of wire cutters and curved mayo scissors.The suprarenal fixation of the previously implanted endologix graft was reportedly left intact so as to not damage the paravisceral aorta.It was reported that the devices were removed piecemeal as it was reportedly difficult to separate them evenly.The physician reportedly fashioned suitable proximal and distal anastomotic sites free of aneurysmal disease with healthy arterial wall to sew to.A 24x12mm dacron graft was used for the juxtarenal aaa repair.The patient was discharged in stable condition on (b)(6) 2021.The explanted devices were discarded at the facility.

• 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
• MDR Report Key: 11570133
• Report Number: 3007284313-2021-01361
• Device Sequence Number: 3521202
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 09/08/2021; 09/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 08/09/2021; 09/17/2021; 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11 FOR LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85