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

Model Number	RLT261416
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the patient was treated for an iliac aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system, a gore® excluder® aaa endoprosthesis, a gore® excluder® iliac branch endoprosthesis, and a gore® viabahn® endoprosthesis with heparin bioactive surface.The patient tolerated the procedure.On the one month follow up visit, it was reported limb compression occurred in the gate area of the main body, causing left leg claudication.The physician plans to reintervene on (b)(6) with kissing vbx stents at the level of the main body flow divider.Received information from fsa.Reintervention was performed on (b)(6) 2022.Physician gained bilateral access and placed bilateral kissing 11 mm vbx stents in the compressed area of the limb.Ivus confirmed patency.Physician reports palpable pulses on the left foot which were previously absent.
Additional Manufacturer Narrative
H6: investigation findings: code 3233 updated to code 213.H6: investigation conclusions: code 11 updated to code 4315.H6: type of investigation code 4118 updated to code 3331 with completion of phr review.

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13484689
• Report Number: 3007284313-2022-01766
• Device Sequence Number: 14793374
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 07/12/2024
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male