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

Catalog Number	PXT261412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional components implanted on (b)(6) 2007 - pxc201200/05072934 (b)(4), pxc181400/05225188 (b)(4).
Event or Problem Description
On (b)(6) 2007, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.At the time of repair the aneurysm measured 6.5 cm.The patient was then lost to follow up.On (b)(6) 2018, the patient had a follow up examination where it was revealed that the aneurysm measured 11.5 cm.Non-contrast computed tomography showed what appeared to be a proximal type i endoleak at the proximal neck, and distal type i endoleaks from both common iliac arteries.A reintervention is planned where the physician stated he will coil the left hypogastric artery, then extend both iliac arteries, as well as snorkel the left renal artery and place a cook aortic cuff at the proximal neck.
Additional Manufacturer Narrative
Manufacturer narrative/corrected data contact office name/address (and manufacturing site for devices)name and address of manufacturer's contact office.

• 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: 7861598
• Report Number: 3007284313-2018-00254
• Device Sequence Number: 19328136
• Product Code: MIH
• UDI-Device Identifier: 00733132610211
• UDI-Public: 00733132610211
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/07/2018

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: 05/31/2010
• Device Catalogue Number: PXT261412
• Device Lot Number: 05170681
• 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
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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: Other