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

Model Number PXA280300

Device Problem Human-Device Interface Problem (2949)

Patient Problem Aneurysm (1708)

Event Date 03/19/2021

Event Type  Injury  

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 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
• Type of Device: 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: 11548072
• MDR Text Key: 242377737
• Report Number: 2953161-2021-01055
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132609895
• UDI-Public: 00733132609895
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: PXA280300
• Device Catalogue Number: PXA280300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 03/22/2021
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 78