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

Catalog Number	PXC201000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/20/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the ifu, the contralateral leg component (pxc201000) is intended to treat aortic diameters ranging from 16.5 to 18.5 mm.It was reported the patient¿s left common iliac artery measured 22.2 mm, therefore, the use of the 20.0 mm contralateral leg component was outside the accepted treatment range.The ifu states, adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral common iliac artery aneurysms with a system of gore excluder aaa endoprostheses.According to the report, the right internal iliac artery was coil-embolized, and intentionally covered by the ipsilateral limb of the trunk-ipsilateral leg component.The procedure concluded with the implantation of two contralateral leg components (pxc141000 and pxc201000- most distal) on the patient¿s left side.According to the report, the contralateral leg component (pxc201000) was undersized for placement within the patient¿s 22.2 mm left common iliac artery, however at the time of the initial implant procedure, a larger device was reportedly not available.Intra-procedural angiography was performed, a distal type i endoleak was observed originating from the most distal contralateral leg component (pxc201000).As it was determined, the endoleak was not communicating with the aneurysmal sac, the physician elected not to perform an additional procedure to treat the endoleak.Final angiography, showed exclusion of all aneurysms and the patient was reported to have tolerated the procedure.According to the report, routine follow-up computed tomography (ct) scans were performed until 2016 with no adverse events being reported.After 2016, the patient reportedly was lost to follow-up.On unknown date in 2018, the patient again sought treatment and a computed tomography scan was performed.Imaging identified evidence of left common iliac aneurysm enlargement (total amount of growth is unknown).On (b)(6) 2018, an intervention was performed to treat the enlarging left common iliac artery.The left internal iliac artery was coil embolized and intentionally covered.A contralateral leg component (plc121400j) was implanted for distal extension into the left external iliac artery.Final angiography showed exclusion of the aneurysm.No further adverse events were reported and 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: 7666500
• Report Number: 2017233-2018-00367
• Device Sequence Number: 1618744
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 12/31/2013
• Device Catalogue Number: PXC201000
• Device Lot Number: 8740199
• 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: 07/06/2018
• 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: 80 YR