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

Model Number	PXA280300
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include but are not limited to: welchol, xarelto, boniva, synthroid, pantoprazole, vytorin, amlodipine, and gabapentin.Patient medical history includes but is not limited to: gastroesophageal reflux disease, hiatal hernia, basal cell carcinoma, pulmonary embolism, hypertension, and osteoporosis.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2021, this patient underwent reintervention for treatment of a proximal type i endoleak.A gore® aortic extender component was placed proximally to extend coverage of a previously implanted gore® aortic extender component.Additionally endoanchors were screwed in to obtain secure transmural fixation.The patient tolerated the procedure and the endoleak was reduced but not fully resolved.

• Brand Name: GORE EXCLUDERAAA 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: 11548072
• Report Number: 2953161-2021-01055
• Device Sequence Number: 11709943
• Product Code: MIH
• UDI-Device Identifier: 00733132609895
• UDI-Public: 00733132609895
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 02/28/2017
• Device Model Number: PXA280300
• Device Catalogue Number: PXA280300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/22/2021
• 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; Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 78