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

Catalog Number	PXL161407
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: rmt281416/11069361 - (b)(4), pxc141200/10963679 - (b)(4), pxl161207/10617720 - (b)(4).Instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and/or require intervention 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) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring the c3 delivery system.The patient tolerated the procedure.On (b)(6) 2019, the patient reported back pain and underwent follow-up imaging which showed a distal type i endoleak and enlargement of the left common iliac artery (lcia)(approximately 4cm in diameter) which the physician attributes to disease progression.No reintervention is scheduled.The diameter of the lcia at the time of original implant was not available.On (b)(6) 2019, the patient underwent reintervention and two additional gore® excluder® iliac extender endoprostheses were implanted to extend coverage distally on the right side, with intentional coverage of the hypogastric artery.Coil embolization of the right hypogastric artery and a femorofemoral bypass were also performed.The patent tolerated the procedure and the endoleak was resolved.
Additional Manufacturer Narrative
Event: additional/corrected information.
Event or Problem Description
On (b)(6) 2019, the patient underwent reintervention and two additional gore® excluder® iliac extender endoprostheses were implanted to extend coverage distally on the left side, with intentional coverage of the hypogastric artery.Coil embolization of the left hypogastric artery and a femorofemoral bypass were also performed.The patent tolerated the procedure and the endoleak was resolved.

• 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: 8311789
• Report Number: 2953161-2019-00012
• Device Sequence Number: 1697441
• Product Code: MIH
• UDI-Device Identifier: 00733132610082
• UDI-Public: 00733132610082
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2019

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: 07/31/2015
• Device Catalogue Number: PXL161407
• Device Lot Number: 10654723
• 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; Not provided
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 02/13/2019; 02/18/2019
• 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; Other; Required Intervention
• Patient Age: 79 YR