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

Catalog Number	PLA260300
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note: two additional gore® excluder® aortic extender components (pla260300/14834638, and pla260300/14241662) have been included in this report, as it is unknown which device was most proximal in the reported type i endoleak.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Imaging evaluation summary: ct images were received by gore from the facility and an imaging evaluation was performed.One time-point was available for evaluation: post-implantation cta dated (b)(6) 2018.There appeared to be a non-gore manufactured device present, with three gore® excluder® aortic extender components at the proximal end of the previously implanted non-gore device.The proximal infrarenal aortic neck appeared to be highly angulated.Amount of device overlap with the non-gore device could not be confirmed.There appeared to be contrast pooling in the aneurysmal sac near the proximal end of the devices to approximately the mid aneurysm level.There also appeared to be calcium within the proximal portion of the left renal artery.The left renal artery appeared to be patent on this time point; images provided did not allow for evaluation in relation to this portion of the reported event.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak.Per ifu, key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation.Per ifu, the safety and effectiveness of the gore excluder® aaa endoprosthesis have not been evaluated in the revision of previously placed stent grafts.
Event or Problem Description
On an unknown date, the patient was implanted with a non-gore manufactured stent-graft to treat an abdominal aortic aneurysm.On (b)(6) 2018, the patient was implanted with three gore® excluder® aortic extender components (pla260300/13956410, pla260300/14834638, and pla260300/14241662) to treat distal migration of the initially implanted stent-graft system.On (b)(6) 2018, follow-up imaging reportedly identified a proximal type i endoleak.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby a ¿snorkel¿ was placed in the left renal artery, the stent graft system was extended proximally, and a bare metal stent was placed in the right renal artery to preserve blood flow.According to the report, the snorkel in the left renal artery became occluded.No further treatment was rendered to treat the occlusion, and the patient tolerated the procedure.The physician will continue to monitor the patient.

• 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: 8056269
• Report Number: 2953161-2018-00097
• Device Sequence Number: 1786665
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: 00733132618774
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 05/31/2018
• Device Catalogue Number: PLA260300
• Device Lot Number: 13956410
• 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: 11/09/2018
• 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: 84 YR