MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT231414J

Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problem Occlusion (1984)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to component migration, occlusion of device or native vessel.

Event Description

On (b)(6) 2019, this patient underwent an endovascular repair for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The physician attempted to deploy a proximal portion of the trunk-ipsilateral leg component just distal to the origin of the right renal artery.The endoprosthesis moved distally and was located slightly more distal than intended.Repositioning was not needed and the procedure was continued.Before deployment of the ipsilateral leg of the trunk-ipsilateral leg component, the bifurcation of the left internal iliac artery was confirmed by angiography.The physician reportedly thought that there was enough space and deployed the leg.However, the left internal iliac artery was unintentionally covered by the leg.A balloon catheter was utilized inside the trunk-ipsilateral leg component to push up the leg, however, it was unsuccessful.The physician also tried to push up the leg using a sheath, however, it was unsuccessful.The procedure was completed.The patient tolerated the procedure and is monitoring by physician.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8856046
• MDR Text Key: 153122221
• Report Number: 3007284313-2019-00235
• 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: 07/24/2019

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: 04/15/2022
• Device Catalogue Number: RLT231414J
• Device Lot Number: 20481403
• 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: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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
• Patient Age: 73 YR