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

Catalog Number	PLA320400
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include but are not limited to: aspirin, carvedilol, escitalopram, fenofibrate, folic acid, gilenya, hydralazine, hydrocodone, lisinopril, naproxen, omeprazole, tolterodine, vimpat, vitamin e, vyvanse, xanax.The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: a minimum aortic neck length of 15 mm.Additionally, the ifu states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, occlusion of the device or native vessel.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The physician had chosen not to perform angioplasty as the patient¿s ascending and proximal mid descending thoracic aorta; down to the bilateral common iliac arteries were reported to have multiple sites of spontaneous chronic arterial dissections.Additionally, it was reported that patient¿s aortic neck length only measured 8-9mm.Intraprocedure imaging showed a proximal type i endoleak and a gore® excluder® aortic extender was implanted with careful angioplasty of the proximal end.Imaging at this time showed the endoleak had been resolved however that the aortic extender component had completely covered the left renal artery.Attempts to maneuver the aortic extender component were made but not successful.A left renal artery to left external artery transposition was then performed.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8336381
• Report Number: 2953161-2019-00015
• Device Sequence Number: 16483180
• Product Code: MIH
• UDI-Device Identifier: 00733132618804
• UDI-Public: 00733132618804
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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: 06/09/2019
• Device Catalogue Number: PLA320400
• Device Lot Number: 15159732
• 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: 02/13/2019
• 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; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 80