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 Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Ischemia (1942); No Code Available (3191)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm.During the procedure, a gore® excluder® trunk-ipsilateral leg component rlt311415 was extended with a gore® excluder® contralateral leg component plc231200 on the patient¿s right side.Additionally, a plc161000 component was extended with a plc181200 component on the left.On an unknown date, the patient presented as an emergency due to a manifestation of bilateral leg ischemia, which partially had affected his right, and completely had affected his left leg.On (b)(6) 2019, computed tomography (ct) imaging identified the rlt311415 component completely compressed apart from its most proximal portion which reportedly had remained fully deployed and fixated to the aorta.The component had thus not migrated towards distal.The physician assessed the rlt component¿s compression was approximately 95% and the overlap zones of the plc components appeared compressed as well, leading to a lack of wall apposition in those zones.As a potential reason for the compression, the physician considered that the patient¿s aortic neck angulation might have caused a type 1a endoleak feeding the aneurysm sac, leading to a pressure increase and compressing the rlt endoprosthesis from the outside.Therefore, also on (b)(6) 2019, an explant of all gore® excluder® endoprostheses apart from the plc181200 component was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6.Patient code 1: corrected code.H6.Patient code 2: added code.Additonal devices explanted with the gore® excluder® trunk-ipsilateral leg component rlt311415/18689885: gore® excluder® contralateral leg component plc231200/17317414, udi: (b)(4).Gore® excluder® contralateral leg component plc161000/18244194, udi: (b)(4).H6, code 3221: the explanted gore® excluder® trunk-ipsilateral leg rlt311415/18689885 was requested but not returned.Therefore, an explant evaluation could not be performed.Additionally, images were requested but not returned.Therefore, an imaging evaluation could not be performed.H6: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H6, code 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak, surgical conversion.

• 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: 9326158
• Report Number: 3007284313-2019-00347
• Device Sequence Number: 2484088
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 10/08/2021
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Device Lot Number: 18689885
• 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: 11/15/2019
• Supplement Report FDA Received Date: 10/28/2020
• 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: Hospitalization; Required Intervention