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

Catalog Number	PLC181000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include acetaminophen, aspirin, glucosamine, lisinopril, multivitamin with minerals, ocular lubricant, simvastatin, ubiquinone, and vitamin e.(b)(4).Imaging evaluation summary ¿ ct images were received by gore from the facility and an imaging evaluation was performed.There appeared to be calcium present in the distal left common iliac artery (lci), with a lack of wall apposition at the distal end of the implanted device on the left side.There appeared to be contrast outside of the distal end of the device on the lci, as well as contrast outside of the device on the arterial and delay phases.Finally, there appeared to be a patent lumbar artery and a distal type i endoleak present.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Per ifu, key anatomic elements that may affect successful exclusion of the aneurysm include significant calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.
Event or Problem Description
On (b)(6) 2017, the patient was implanted with four gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Computed tomography (ct) images received on october 15, 2018, reportedly revealed a lack of distal device apposition to the vessel wall on the left side, contributing to a type ib endoleak.Aneurysmal growth was reportedly noted in the left common iliac artery (amount unknown).A type ii endoleak was also reportedly identified.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby the aneurysm was coil-embolized, and an additional stent graft was implanted distally on the left side to treat the type ii and ib endoleaks, respectively.The endoleaks were resolved and the patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8055955
• Report Number: 2953161-2018-00096
• Device Sequence Number: 1526626
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 06/03/2019
• Device Catalogue Number: PLC181000
• Device Lot Number: 15138876
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 72