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

Model Number	PXC161200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown which gore(r) excluder(r) component was involved with the reported event, an additional device will be included on this report: pxc161400 / 06322842.Patient medications include aspirin, clindamycin, crestor, pepcid, flonase, claritin, lopressor, multivitamin, and nitrostat.Results pending completion of manufacturing evaluation.It should be noted the gore(r) excluder(r) aaa endoprosthesis instruction for use states "adverse events that may occur and/or require intervention include, but are not limited to, aneurysm enlargement.".
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular treatment of a left common iliac artery aneurysm using two gore(r) excluder(r) contralateral leg components.On (b)(6) 2021, the patient presented with aneurysmal dilatation of the left iliac artery.On the same day, the patient underwent a re-intervention procedure whereby coil embolization of the left internal iliac artery was performed, and an additional gore(r) excluder(r) device was implanted to extend the stent graft system distally.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 ¿ a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.H6: conclusion code updated.It should be noted the gore® excluder® aaa endoprosthesis instruction for use states ¿adverse events that may occur and/or require intervention include, but are not limited to, aneurysm enlargement.¿.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11280143
• Report Number: 2017233-2021-01649
• Device Sequence Number: 11779613
• Product Code: MIH
• UDI-Device Identifier: 00733132609987
• UDI-Public: 00733132609987
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/25/2021

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: 09/30/2011
• Device Model Number: PXC161200
• Device Catalogue Number: PXC161200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80