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

Catalog Number	PXC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include acetorin, brovana, pulmicort, plavix, lisinopril, cardura, neurontin, hydralazine, norco, atrovent, imdur, lopressor, nitro-stat, and crestor.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Imaging evaluation results: ct images dated (b)(6) 2018 were received by gore from the facility and an imaging evaluation was performed.Centerline reconstruction illustrated what appeared to be 14mm of seal of the 20mm contralateral leg component on the right (ipsilateral) side.The distal 2cm of the contralateral leg component did not appear to have seal along the vessel wall of the right common iliac artery.Axial imaging illustrated a lack of distal wall apposition of the contralateral leg component.Per the gore® excluder® aaa endoprosthesis instructions for use, patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.
Event or Problem Description
On (b)(6) 2010, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.On an unknown date, a follow-up computed tomography (ct) scan reportedly showed aneurysmal disease progression into the right common iliac artery.No endoleak or loss of distal apposition was initially reported.On (b)(6) 2019, a re-intervention procedure was performed whereby the right hypogastric artery was coil-embolized, and an additional excluder® component was implanted to extend the stent graft system distally into the right external iliac artery.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: 8320103
• Report Number: 2017233-2019-00071
• Device Sequence Number: 14042901
• Product Code: MIH
• UDI-Device Identifier: 00733132610051
• UDI-Public: 00733132610051
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/10/2019

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: 10/31/2012
• Device Catalogue Number: PXC201400
• Device Lot Number: 7319360
• 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: 02/08/2019
• 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: 79 YR
• Patient Weight: 73