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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	01/27/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient medications include but are not limited to: atorvastatin, lopressor, aspirin.Concomitant medical products: patient medical history includes but is not limited to: hypertension, hyperlipidemia, cad, asthma, smoker, shingles.The instructions for use (ifu) states: the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: revision of previously placed stent grafts.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular reintervention for treatment of a proximal type i endoleak associated with a previously implanted endologix abdominal stent graft system.A gore® excluder® trunk ipsilateral leg component was implanted to reline the endologix graft.It was reported that the trunk ipsilateral leg component had been deployed too far proximal, landing behind the top end of the endologix graft leaving a separation and a type iii endoleak.The patient was coverted to open repair and the grafts were explanted.During the conversion, it was reported that the patient endured an aortic rupture.The patient tolerated the procedure.On (b)(6) 2021, it was reported that patient expired.The cause of death was thought to be due to the aortic rupture.

• 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: 11298056
• Report Number: 3007284313-2021-01242
• Device Sequence Number: 10945008
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 10/28/2023
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/08/2021
• 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: Death; Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 67