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

Catalog Number	PLL161407
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient, therefore an engineering investigation could not be conducted.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to improper component placement, occlusion of device or native vessel and endoleak.The ifu states: 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 access techniques.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® conformable aaa endoprostheses and gore® excluder® aaa endoprostheses.Reportedly, due to the tortuous anatomy, two back-up maier wires were introduced at the contralateral side to straighten the anatomy.After the deployment of the trunk ipsilateral leg endoprosthesis, the cannulation of the contralateral gate was successfully performed.However, after the placing of the planned gore® excluder® aaa endoprosthesis at the contralateral side, the proximal limb appeared not inside the contralateral gate.According to the information provided, the physicians used the wrong guidewire to introduce the prosthesis and it caused the deployment of the limb outside the gate.A second trunk ipsilateral leg endoprosthesis was introduced changing the treatment into an aorto-uni-iliac (aui) procedure.Reportedly, there was an endoleak but it was solved by doing the aui procedure.The limbs at the contra-lateral side, were occluded using an occluder plug and a femorofemoral crossover bypass procedure was performed.At the end of the or the patient was doing fine with all vessels patent and the aneurysm excluded.

• 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: 8834227
• Report Number: 3013164176-2019-00095
• Device Sequence Number: 2390111
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: 00733132618767
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 01/21/2022
• Device Catalogue Number: PLL161407
• Device Lot Number: 20131037
• 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: 07/26/2019
• 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: 80 YR