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

Catalog Number	PXT261414
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/18/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).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 component migration, endoleak and aneurysm enlargement.According to the ifu, additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.According to the sizing guidelines for the pxt261414 device the aortic inner diameter range is 22 - 23mm.Reportedly the maximum aortic neck diameter in the landing zone was 24mm.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 a minimum aortic neck length of 15 mm.Key anatomic elements that may affect successful exclusion of the aneurysm include short proximal aortic neck.
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular procedure using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The pre-treatment maximum diameter of the aortic aneurysm/lesion was 50mm.The patient tolerated the initial procedure.Reportedly, from (b)(6) 2012 to august 20, 2018, the maximum diameter of aortic aneurysm/lesion increased in size from 51mm to 92mm.On (b)(6) 2018, a proximal type i endoleak due to the device migration (unknown amount) was determined.Reportedly, the type i endoleak caused the aneurysm enlargement.According to the information provided, the patient¿s anatomy contributed to the event, as the aortic neck was short.On (b)(6) 2019, the patient underwent the additional procedure using an aortic endograft (unknown) to treat the endoleak and the aneurysm enlargement.The follow up ultrasound on (b)(6) 2019, showed that the diameter of aneurysm was 91mm.No further adverse events have been reported.

• 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: 8480359
• Report Number: 2017233-2019-00217
• Device Sequence Number: 16552568
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 12/31/2013
• Device Catalogue Number: PXT261414
• Device Lot Number: 8701894
• 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: 04/03/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: 82 YR
• Patient Weight: 57