MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT311415
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 the patient presented with a ruptured and bleeding abdominal aortic aneurysm.Reportedly the patient had a pre-existing endologix device with a proximal type i endoleak.The endologix device was relined using gore® excluder® aaa endoprostheses.On (b)(6) 2020 the patient complained of belly pain.A ct was performed and a proximal type i endoleak was reported on the gore® excluder® trunk-ipsilateral leg component.It was reported that the endoleak was caused by the endologix device not allowing the trunk to fully expand.Aptus staples were placed to resolve the endoleak.On (b)(6) 2020 the endoleak persisted, and the physician reportedly converted to open repair.The trunk of the trunk-ipsilateral leg component was reportedly cut at the flow divider.The trunk of the gore® excluder® and the endologix device were explanted.The ipsilateral limb and contralateral leg component remained implanted.A tube graft was reportedly sewn into the patient's proximal aortic neck, and attached to the flow divider thus connecting the tube graft to the remaining excluder® limbs distally.The patient reportedly tolerated the procedure.
Additional Manufacturer Narrative
H.6.Results code 1: code 213 ¿ the review of the manufacturing paperwork verified that the lot met all pre-release specifications.H.6.Conclusions code 1: code 18 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), 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.Conclusions code 2: code 22 - according to the gore® excluder® aaa endoprosthesis ifu, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak and surgical conversion.According to the gore® excluder® aaa endoprosthesis ifu, any modifications made to the device may cause serious surgical consequences or injury to the patient.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9945906
• Report Number: 3007284313-2020-00096
• Device Sequence Number: 3358592
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 08/09/2022
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Device Lot Number: 20951367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Required Intervention