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

Model Number	PXC201200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that this event was also reported in medwatch(es) # 3013164176-2020-00073 and # 2953161-2020-00013.Details of the event required a separate medwatch submission for component identified; as such this medwatch is being submitted.According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoleak, 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) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm measuring approximately 45mm in diameter, and was implanted with gore® excluder® aaa endoprosthesis.In the beginning of (b)(6) 2020, follow-up imaging revealed aneurysm enlargement to approximately 60 mm in diameter and a type ii endoleak from the l4 lumbar artery.Additionally, a proximal type i endoleak was determined along with a type iii endoleak due to component disconnect of the contralateral leg component from the contralateral gate.On (b)(6) 2020, a reintervention was performed and an endurant cuff was placed to treat the proximal type i endoleak, and a contralateral leg component was placed to treat and reline the type iii endoleak.No treatment for the type ii endoleak was performed but future treatment is planned.The type i endoleak was reported to have not been resolved by placement of the endurant cuff.The patient tolerated the procedure.

• 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: 10108639
• Report Number: 2017233-2020-00392
• Device Sequence Number: 3406069
• Product Code: MIH
• UDI-Device Identifier: 00733132610044
• UDI-Public: 00733132610044
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 11/30/2014
• Device Model Number: PXC201200
• Device Catalogue Number: PXC201200
• Device Lot Number: 9892109
• 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: 06/02/2020
• 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: 82 YR