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

Catalog Number RLT231216J

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem Occlusion (1984)

Event Date 06/25/2019

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), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.Gore® excluder® aaa endoprosthesis instructions for use recommends: determine accurate size of anatomy and proper size of device to confirm the correct device component sizing, and deployment locations.The length of the gore® excluder® aaa endoprosthesis should be sufficient to reach from just inferior to the most distal (lowest) major renal artery to non-aneurysmal tissue in the common or external iliac arteries it is recommended to view and confirm the distal position of the iliac end of the device relative to the internal iliac artery to ensure accurate and desired deployment position of the distal aspect of the device.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 and occlusion of device or native vessel.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, the physician pushed up the delivery catheter during the deployment of the ipsilateral leg and during the delivery catheter removal, it was noticed that the leg moved distally and unintentionally covered the left internal iliac artery.The physician attempted to pull up the leg using balloon catheter but it was not successful.It was also tried to cannulate the left internal iliac artery using a guide wire, but was not successful.The physician decided to monitor the covered left internal iliac artery.The patient tolerated the procedure.The physician stated that the ipsilateral leg was too long because the length of the main body was not measured with a marker pig catheter.Since the proximal neck of patient¿s aorta was very tortuous, it seemed that the blood vessel was shortened by using a stiff guide wire.

• 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: 8800956
• MDR Text Key: 151419291
• Report Number: 3007284313-2019-00207
• 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: 06/25/2019

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: 03/13/2022
• Device Catalogue Number: RLT231216J
• Device Lot Number: 20353842
• 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: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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: 77 YR