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

Catalog Number PLA260300J

Device Problem Device Handling Problem (3265)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the procedure, the physician deployed a contralateral leg while pushing it proximally, which resulted proximal movement.The proximal end of contralateral leg was 1 cm more proximal to the level of the long radiopaque marker.A type ia endoleak was found after deployment of trunk-ipsilateral leg endoprosthesis and contralateral leg; therefore, an aortic extender was additionally placed 5 mm proximal to the trunk-ipsilateral leg endoprosthesis.When deploying the aortic extender, the distal end was interfered with the contralateral leg.This caused migration of the aortic extender, and the left renal artery and the right accessory renal artery were unintentionally covered by the stent graft.No blood flow into these arteries was noted.A gore® viabahn® vbx balloon expandable endoprosthesis (7 mm x 29 mm) was additionally implanted in the left renal artery.Blood flow was recovered.The patient tolerated the procedure.

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the procedure, the physician deployed a contralateral leg while pushing it proximally, which resulted proximal movement.The proximal end of contralateral leg was 1 cm more proximal to the level of the long radiopaque marker.A type ia endoleak was found after deployment of trunk-ipsilateral leg endoprosthesis and contralateral leg; therefore, an aortic extender was additionally placed 5 mm proximal to the trunk-ipsilateral leg endoprosthesis.When deploying the aortic extender, the distal end was interfered with the contralateral leg.This caused migration of the aortic extender, and the left renal artery was unintentionally covered by the stent graft.No blood flow into these arteries was noted.A gore® viabahn® vbx balloon expandable endoprosthesis (7 mm x 29 mm) was additionally implanted in the left renal artery.Blood flow was recovered.The patient tolerated the procedure.

Manufacturer Narrative

B5: description of event corrected to indicate that only the left renal artery was unintentionally covered by the stent graft.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14280899
• MDR Text Key: 290687842
• Report Number: 3013164176-2022-01363
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

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 Catalogue Number: PLA260300J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Treatment: PLC161400J/ (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male