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

Catalog Number	PXT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): additional device: pxc141000 udi information: (b)(4).It is unknown which device was in the left iliac region, therefore both were investigated.Results: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2007 a patient underwent treatment with gore® excluder® aaa endoprostheses trunk ipsilateral leg component (pxt281416/04779224) and a contralateral leg component (pxc141000/04777940).On (b)(6) 2007, the patient went in for a second procedure to place an aortic extender (pxa2803000/04702076).(captured event # (b)(6)).On (b)(6) 2018, a reintervention took place to treat disease progression noted in the left common iliac artery.A gore® excluder® iliac branch endoprosthesis was utilized to treat this.It was not possible to preserve the internal iliac artery, however there were no reported problems with the device itself, so this vessel was coil embolized.The right common iliac was slightly aneurysmal but it was decided not to treat this area at this time.

• 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: 7775175
• Report Number: 2953161-2018-00071
• Device Sequence Number: 19162487
• Product Code: MIH
• UDI-Device Identifier: 00733132610310
• UDI-Public: 00733132610310
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: 11/30/2009
• Device Catalogue Number: PXT281416
• Device Lot Number: 04779224
• 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: 08/11/2018
• 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; Other; Required Intervention
• Patient Age: 69 YR