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

Model Number	RLT311417
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc141200/22125416.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for left common iliac artery aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system, and gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure and the outcome was reported to have been successful.On (b)(6) 2020, follow-up imaging determined a type iii endoleak (disconnect) on the left side between the iliac branch component and the contralateral leg component used as the bridge graft.The physician believes elongation of the aneurysmal area and tortuosity of the patient's iliac arteries attributed to the disconnect.Additionally, on the right side a type iii endoleak (disconnect) was determined to be present involving the ipsilateral leg and an iliac extender component, believed to have been caused from the tortuosity of the patient's anatomy on (b)(6) 2020, the patient underwent reintervention and both sides were relined.The patient tolerated the procedure and the endoleaks were resolved.

• 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: 12221801
• Report Number: 3007284313-2021-01522
• Device Sequence Number: 4508031
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 02/06/2023
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 07/23/2021
• 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; Other; Required Intervention
• Patient Age: 71 YR