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

Catalog Number RLT231412J

Device Problem Collapse (1099)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

The pll161407j device is being reported separately.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 endoprosthesis occlusions.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A trunk ipsilateral leg endoprosthesis (rlt231412j), an iliac extender endoprosthesis in the left limb (pll161407j) and a contralateral leg endoprosthesis (plc141200j) in the right limb were implanted.Angiography revealed that the plc141200j was slightly narrow due to the terminal aorta being narrow.Ballooning was performed in kissing technique and a stent was implanted in the plc141200j.No issue of blood flow disturbance was identified angiographically and the procedure was concluded.After the procedure ended, during the night, the patient complained of pain in the left limb.Angiography showed that the ipsilateral leg of the rlt231412j was compressed.A stent was implanted in the ipsilateral leg, but the blood flow to the left limb did not improve.An additional stent was implanted from the pll161407j to the external iliac artery.Reportedly, there was resistance when a guide wire was advanced inside the ipsilateral leg.It seemed that the stent graft was patent by angiography, however the blood flow was not improved.(the physician suggested the possibility of the stent graft occlusion and/or stenosis) a femoral-femoral bypass procedure was performed.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• 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
• MDR Report Key: 11467586
• MDR Text Key: 239710321
• Report Number: 2017233-2021-01756
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: 05/31/2023
• Device Catalogue Number: RLT231412J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 72 YR