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

Catalog Number	PLA360400
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown which device may have contributed to this event two additional gore® excluder® iliac branch endoprostheses used in the procedure will be listed.Pla360400, lot#20083286, udi: (b)(4).Pla360400 lot#20204588.(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to: improper component placement.
Event or Problem Description
On (b)(6) 2019, the patient presented with a previously placed aneurx stent graft that was used to treat an abdominal aortic aneurysm (aaa).The top of the aneurx graft was now positioned over 4 cm below the lowest renal artery (right renal).The physician decided to place three gore® excluder® aaa endoprostheses.After placement of all three 36mm cuffs, the physician ballooned the cuffs in place to solidify placement and to balloon the appropriate junctions.During the final angio run to check for endoleaks, the lowest renal appeared to have some graft infringing upon it.The physician isolated the right renal using a catheter and decided to place a 6mm x 16mm icast stent graft in order to ensure patency.The icast stent was deployed successfully and the endoleak was resolved.The patient is reportedly doing well.

• 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: 8799587
• Report Number: 3013164176-2019-00086
• Device Sequence Number: 19589886
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/01/2019

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: 12/02/2021
• Device Catalogue Number: PLA360400
• Device Lot Number: 19951205
• 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: 07/17/2019
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 80