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

Model Number	PXT231414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Perforation of Vessels (2135)
Date of Event	11/30/2010
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #: pxc181000 / serial #: (b)(4) / udi #: (b)(4).Catalog #: pxc201200 / serial #: (b)(4) / udi #: (b)(4).Patient weight: asked but unavailable.Outcomes attributed to adverse event - death - date of patient death: as the date of patient death is reportedly unknown, but reported as around (b)(6), the date of patient death has been estimated as (b)(6) 2020.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.
Event or Problem Description
On (b)(6) 2010, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A type ii endoleak was detected at final angiography.The patient tolerated the procedure.On an unknown date in early (b)(6) 2020 a proximal type i endoleak, a distal endoleak on both the right and left side, and aneurysm enlargement were confirmed.A re-intervention and additional stent graft placement on both the proximal and distal sides was planned for (b)(6) 2020.However, on an unknown date in mid (b)(6) 2020 (reported as around (b)(6)) the patient expired due to aneurysm rupture.It was reported that the attending physician was unable to obtain detailed information regarding the patient's death.
Additional Manufacturer Narrative
H.6.Results code 1 updated.H.6.Conclusions code 1 updated.H.6.Conclusions code 2 added.H.6.Conclusions code 2: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak, aneurysm enlargement, aneurysm rupture and death.Furthermore, the ifu informs users of the risks associated with type ii endoleaks, and users are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.

• 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: 10525800
• Report Number: 2017233-2020-01249
• Device Sequence Number: 11622502
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: 00733132610143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 06/30/2013
• Device Model Number: PXT231414
• Device Catalogue Number: PXT231414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: Death
• Patient Age: 82 YR