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

Model Number	PXT311413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which device caused this adverse event so all system components are being included on this report.Additional system components involved in this adverse event include: item #pxc141400/lot #11323580/udi #(b)(4).Item #pxc181400/lot #11075729/udi #(b)(4).
Event or Problem Description
On (b)(6) 2013 a tevar procedure was performed whereby a gore® tag® thoracic endoprosthesis was implanted to bridge a previously performed elephant trunk procedure and a previously implanted gore® tag® thoracic endoprosthesis.Following the tevar procedure, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020 a thoracoabdominal aneurysmorrhaphy was performed to prevent an impending rupture of the abdominal aortic aneurysm due to aneurysm enlargement.Reportedly the amount of aneurysm enlargement is unavailable.No suspected cause of aneurysm enlargement was reported.There were no further reported issues in relation to the gore® excluder® aaa endoprostheses.The patient tolerated the procedure.
Additional Manufacturer Narrative
Results code 1 updated results code 1: code 213 ¿ the review of the manufacturing paperwork verified that the lots met all pre-release specifications.Conclusions code 1 updated.Conclusions code 2 added.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, aneurysm enlargement.
Additional Manufacturer Narrative
Method code 3: code 4112 - images were provided, and an imaging evaluation was performed.Results code 3: code 3207 - the imaging evaluation states the following: centerline reconstruction from ct dated (b)(6) 2015 illustrates the gore® excluder® device appears to be about 16mm distal to the right renal artery.Centerline reconstruction from ct dated (b)(6) 2019 illustrates the gore® excluder® device appears to be about 36mm distal to the right renal artery.Axial image from ct dated (b)(6) 2019 illustrates contrast in the aneurysmal sac.Axial image from ct dated (b)(6) 2019 illustrates a patent ima.Axial images illustrating the max diameters from ct¿s dated: (b)(6) 2015: 63mmx57mm.(b)(6) 2019: 75mmx72mm.(b)(6) 2019: 82mmx78mm.(b)(6) 2019: 82mmx79mm.Conclusion codes remain unchanged 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, component migration, endoleak, and aneurysm enlargement.
Additional Manufacturer Narrative
H6: code 213 - a review of the sterilization records confirmed that all lots met all pre-release specifications.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9826176
• Report Number: 2017233-2020-00176
• Device Sequence Number: 16911239
• Product Code: MIH
• UDI-Device Identifier: 00733132610334
• UDI-Public: 00733132610334
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/18/2020

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: 10/31/2015
• Device Model Number: PXT311413
• Device Catalogue Number: PXT311413
• Device Lot Number: 10850556
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/11/2020; 08/19/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 80