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

Catalog Number PLA320400J

Device Problem Human-Device Interface Problem (2949)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/09/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the procedure, a proximal type i endoleak was confirmed.An aortic extender endoprosthesis (pla320400j) was implanted to treat the endoleak and slightly cover the renal artery due to short proximal neck seal zone, but unintentionally covered the left renal artery about 50-60%.A bare stent was implanted in the left renal artery.The left renal artery was preserved.The endoleak was resolved.

Manufacturer Narrative

H6: conclusion code changed from 61 to 4315.

• 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: 12281729
• MDR Text Key: 265207619
• Report Number: 3013164176-2021-01220
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Catalogue Number: PLA320400J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• 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
• Treatment: RLT311417J/22612923; RLT311417J/22612923
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male