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

Catalog Number RLT281416J

Device Problem Device Handling Problem (3265)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/11/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The deployment of the ipsilateral leg resulted in unintentional coverage of left internal iliac artery.The physician attempted to push up the ipsilateral leg with a balloon catheter while the balloon was inflated; however, blood flow of the left internal iliac artery did not improve.Pre-procedure measurement was performed correctly, and the appropriate device was selected.The physician reportedly stated that push-up during the deployment was insufficient.On (b)(6) 2021, the patient complained about numbness of the left leg.Ct revealed stenosis of the ipsilateral leg due to compression by the contralateral leg.The physician commented that blood flow in the ipsilateral leg was normal during the procedure.The contralateral leg endoprostheses had more expansive force than the ipsilateral leg and this imbalance of expansive force might have affected the event.On (b)(6) 2021, the planned additional procedure was performed to treat stenosis of the ipsilateral leg.A bare-metal stent (epic vascular stent, 12 mm x 4 cm) was placed in the ipsilateral leg.The patient tolerated the procedure and his condition was favorable.

Manufacturer Narrative

H6: added component code 515.H6: added investigation conclusion code 4311.

• 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: 12136106
• MDR Text Key: 260606538
• Report Number: 3007284313-2021-01495
• 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,Followup
• Report Date: 12/17/2021

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: 09/06/2023
• Device Catalogue Number: RLT281416J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2020
• 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: 81 YR
• Patient Sex: Male