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

Catalog Number PLC201200J

Device Problem Material Invagination (1336)

Patient Problem Aneurysm (1708)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.

Event Description

On (b)(6) 2019, the patient underwent treatment of an abdominal aortic aneurysm with gore excluder® aaa endoprostheses.The patient tolerated the initial procedure.On (b)(6) 2019, a computed tomography was performed before the patient was discharged, and it was observed that the gore excluder® aaa endoprosthesis contralateral leg component (plc201200j/18244915) was collapsed at the level of the aortic bifurcation.The lumen of the ipsilateral leg was narrowed, but no abnormal blood pressure was observed in the leg.The vessel measurements at the level of the aortic bifurcation was reported 18.1 x 16.0 mm and 17.5 x 17.1 mm.According to the information provided, both the anatomy (narrow terminal aorta) and implanting two endoprostheses in the contralateral leg were contributed to the partially compression of the ipsilateral leg.On (b)(6) 2019, the patient underwent the additional procedure and the contralateral leg component was implanted to prevent future obstruction due to collapse of the ipsilateral leg.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8321277
• MDR Text Key: 135566939
• Report Number: 3013164176-2019-00016
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2019

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: 06/13/2021
• Device Catalogue Number: PLC201200J
• Device Lot Number: 18244915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• 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; Required Intervention
• Patient Age: 78 YR