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

Catalog Number RLT261218J

Device Problem Device Handling Problem (3265)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment for abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.After deployment of the trunk-ipsilateral leg endoprosthesis, a gore® dryseal flex introducer sheath (dsf1833) was inserted into the right side to add an iliac extender to the ipsilateral leg.The dsf was touching the ipsilateral leg and the trunk-ipsilateral leg endoprosthesis moved proximally about 1 cm.The left renal artery was partially covered by the device.Blood flow into the left renal artery was found to be delayed by angiogram.Therefore, a bare-metal stent (6 mm x 18 mm) was placed in the left renal artery and the blood flow improved.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER AAA 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12247524
• MDR Text Key: 264722974
• Report Number: 3007284313-2021-01528
• 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: 07/29/2021

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: 02/29/2024
• Device Catalogue Number: RLT261218J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/29/2021
• Date Device Manufactured: 03/02/2021
• 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): Required Intervention
• Patient Age: 74 YR