MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PXT281418
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2010, this patient underwent an emergency endovascular treatment for the ruptured abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Reportedly, the aneurysm size was about 9 cm.On an unknown date, postoperative follow-up, a tendency of migration of the left leg/ipsilateral leg was confirmed.The amount of the migration was unknown.On (b)(6) 2021, follow-up ct scan showed migration of the left leg into the aneurysm sac, resulting in a distal type i endoleak.On (b)(6) 2022, a reintervention was performed.An additional stent graft was implanted into the left distal side.It was reported that the endoleak was fixed.The patient tolerated the procedure.It was reported that the size of the distal left leg at the index procedure may have been undersized, however, the treatment length for the index procedure was unknown.Additionally, no comment was received from the physician regarding the cause of migration.
Additional Manufacturer Narrative
The device remains implanted and is not available for investigation.(b)(4).The cause of the device migration is unknown.The treatment length was requested but it was unknown.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 endoprosthesis migration and endoleak.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Gore recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10 ¿ 21% oversizing) and 1 mm larger than the iliac inner diameter (7 ¿ 25% oversizing).The length of the gore® excluder® aaa endoprosthesis should be sufficient to reach from just inferior to the most distal (lowest) major renal artery to non-aneurysmal tissue in the common or external iliac arteries.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff ; 9285263030
• MDR Report Key: 13431172
• Report Number: 2953161-2022-01120
• Device Sequence Number: 2045895
• Product Code: MIH
• UDI-Device Identifier: 00733132610327
• UDI-Public: 00733132610327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/02/2022

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: 09/30/2012
• Device Model Number: PXT281418
• Device Catalogue Number: PXT281418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/02/2022
• Date Device Manufactured: 10/23/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male