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

Model Number	PLA360400
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's medical history includes but is not limited to: abdominal aneurysm, high blood pressure, high cholesterol, stroke, transient ischemic attack.Patient's medications include but are not limited to: simvastatin, ampodipine, aspirin, and fish oil.
Event or Problem Description
On (b)(6) 2021, follow-up imaging showed a proximal type i endoleak.Dilation of the proximal aorta was reported and measured approximately 32 mm to 34mm.The physician plans to reintervene on the patient but has not yet scheduled it.Previous medical history for the patient and previously reported is as follows: on (b)(6) 2012, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2016, follow-up imaging identified a possible proximal type i endoleak and aneurysm enlargement of 1 cm.It was reported the cause of the endoleak is unknown.On the same day, an aortic extender component was implanted extending proximally from the trunk-ipsilateral leg component to treat the proximal endoleak.Final imaging identified the endoleak was resolved.The patient tolerated the procedure.
Event or Problem Description
On december 29, 2021, it was reported that the patient was transferred to another physician and is no longer being followed.
Additional Manufacturer Narrative
H6: code 213: a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13056762
• Report Number: 2953161-2021-01112
• Device Sequence Number: 11139514
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 04/30/2018
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG