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

Model Number	PXT261214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc121200/06615502, udi: (b)(4).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.
Event or Problem Description
On (b)(6) 2009 the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a proximal type i endoleak (date and modality of images is unknown).There is aneurysm sac enlargement reported (amount is unknown).The cause for the type i endoleak is unknown.On (b)(6) 2020, the physician reintervened and implanted a gore® excluder® aortic extender endoprosthesis proximally and iliac extender endoprostheses bilaterally distally.The physician wanted further distal coverage in both common iliac arteries.The endoleak was resolved at the end of the case.The patient tolerated the procedure.
Additional Manufacturer Narrative
Code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Code 22-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Additional Manufacturer Narrative
Correction "it has been determined there is no allegation of deficiency on the pxc121200/06615502 device (b)(6).Device has been removed from the complaint.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (ORIGINAL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9919007
• Report Number: 2017233-2020-00229
• Device Sequence Number: 3272423
• Product Code: MIH
• UDI-Device Identifier: 00733132610181
• UDI-Public: 00733132610181
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2020

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: 02/29/2012
• Device Model Number: PXT261214
• Device Catalogue Number: PXT261214
• Device Lot Number: 06598511
• 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: 04/02/2020
• Supplement Report FDA Received Date: 05/21/2020; 08/20/2020
• 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; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 79