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

Model Number	RMT311413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that the patient presented on (b)(6) 2013, with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprostheses.On (b)(6) 2019, the endoprosthesis was explanted due to aneurysm rupture.It was stated that the rupture was probably caused by an aorto-cave fistula that appeared to be visible on pre-explant images dated (b)(6) 2019.An aorto-bi-femoral bypass was performed.The patient state has deteriorated, palliative care was decided.The patient expired on (b)(6) 2019.
Additional Manufacturer Narrative
Code 10: the following is a summary of the explant investigation observations: level 1 analysis: tissue present: yes.Scattered plaques of dark red/brown, yellow, and tan tissue were present on the abluminal surface.A foci of yellow and brown tissue (gelatinous in appearance) was present on the abluminal surface of cl-1, just distal to the contralateral gate.The lumens were patent with minimal, scattered plaques of red/brown tissue present.A foci of tan tissue was present in the distal lumens of both cl-1 & cl-2.Cl-1 was seated within and extended distally from the contralateral gate of the trunk.Cl-2 was seated within and extended distally from the ipsilateral leg of the trunk.No material findings were identified.Request for additional analysis: yes.Reason: to better understand the material integrity of the devices and the composition of the foci of yellow and brown tissue on the abluminal surface of cl-1 in the level 1 report, a level 2 post-digest analysis report was requested and performed by geprovas.Level 2 analysis: the foci of yellow and brown tissue on the abluminal surface of cl-1 was removed and subjected to histopathologic sampling by geprovas.A pathologist with w.L.Gore & associates reviewed images of the masson¿s trichrome and hematoxylin eosin slides.The tissue was consistent with degenerate thrombus with partial collagen organization.White deposits of material (presumptive calcification) were present on the abluminal surfaces.Two areas of radial film wrap disruption, intermixed with calcification deposits, were present on the main body of the trunk.The radial film wrap disruptions were consistent with in-vivo wear of the device in an area of severe calcification.A wire disruption was present in the waist region of the trunk, just distal to the area of bifurcation.The disrupted wire surfaces presented in a flat manner with a ¿shiny¿ material appearance, which is typically associated with a recent fatigue loading event (presumptive fracture).However, the exact cause and time of the fracture can not be determined with the information provided.Material disruptions (i.E., radial film disruptions, wire fracture) are consistent with those caused by in-vivo wear.The was no observable or reported impacted associated with the material disruptions identified.Based on the explant investigation review of the geprovas reports no additional analysis is requested.
Additional Manufacturer Narrative
H6: health effect- impact code added.
Additional Manufacturer Narrative
H6: component code 4755 added g1: manufacturing site and address corrected.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jörg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10635049
• Report Number: 3007284313-2020-01097
• Device Sequence Number: 2438790
• Product Code: MIH
• UDI-Device Identifier: 00733132610747
• UDI-Public: 00733132610747
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2022

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
• Device Expiration Date: 06/30/2015
• Device Model Number: RMT311413
• Device Catalogue Number: RMT311413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 03/09/2022; 03/10/2022
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 09/06/2021; 03/09/2022; 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG