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

Catalog Number	PXT261214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which device caused this adverse event.Additional system components involved in this adverse event include: item #pxc121200/lot #7758597/ udi #(b)(4).The review of the manufacturing paperwork verified that the lots met all pre-release specifications.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 and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2010, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that, on an unknown date, a computerized tomography scan identified aneurysm enlargement.Reportedly the amount of aneurysm enlargement is unknown.The physician performed an angiogram in order to determine the cause of the aneurysm enlargement.The cause of the enlargement was unable to be determined, and no endoleaks were identified.The physician noted that the previously implanted contralateral leg component (lot #7758597) appeared to be, "sitting low," in the gate of the trunk-ipsilateral leg component (lot #06809135).It was reported that on (b)(6) 2019 a reintervention was performed as a precautionary measure to attempt to teat the unidentified aneurysm enlargement.Reportedly a contralateral leg component was used as a bridging mechanism between the previously implanted contralateral and trunk-ipsilateral leg components.There were no further reported issues.The patient tolerated the procedure.

• 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: 8438775
• Report Number: 2017233-2019-00156
• Device Sequence Number: 2241730
• Product Code: MIH
• UDI-Device Identifier: 00733132610181
• UDI-Public: 00733132610181
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/20/2019

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: 05/31/2012
• Device Catalogue Number: PXT261214
• Device Lot Number: 06809135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2019
• 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
• Patient Age: 80 YR