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

Model Number	PLC121400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Numbness (2415); Thrombosis/Thrombus (4440)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a patient was implanted with a 12mm x 14cm and 14mm x 14cm gore® excluder® aaa endoprosthesis (excluder device) to treat arteriosclerosis obliterans of both lower limbs.The physician confirmed by angiography that the renal artery occlusion, the common iliac and external iliac arteries occlusion, and the lateral superficial femoral arteries occlusion.The left renal artery was lower than the right renal artery.The physician advanced 7-120mm baiduoli balloon catheter through the guide wire to dilate the abdominal aorta and bilateral iliac arteries.The angiography showed that the blood flow of the left kidney was limited, and the blood flow of the bilateral iliac arteries was good.Two excluder devices were implanted in bilateral iliac arteries.One 7-120mm baiduoli bare stent was placed on the left and right sides, and 2cm overlapped with the gore device.A 6-19mm baiduoli bare stent was implanted in left renal artery.The angiography showed that the bilateral renal arteries, the abdominal aorta, iliac artery and femoral artery were patent.The patient didn't experience adverse event during and after operation.He was discharged from the hospital on (b)(6) 2021.The patient took aspirin + rivaroxaban anticoagulant as doctor's advice to prevent stent thrombosis.On (b)(6) 2021, the patient went to the hospital because of "pain and numbness of the left lower limb".After examinations, he was preliminarily diagnosed as arteriosclerosis obliterans of the left lower limb (thrombosis formed in the stent?).On (b)(6) 2021, the patient was received reintervention.The physician gradually advanced the guide wire and single curved catheter to the abdominal aorta and stents.The angiography showed that the opening of gore device (12mm x 14cm) on the left side of the abdominal aorta was narrow and occluded, and the left iliac artery was narrow.One 8-80mm baiduoli balloon was used to dilate the proximal end of the stent, and 8-100mm abbott bare stent was implanted.A 6-150mm baiduoli balloon was used to dilate the left iliac artery.The angiography showed that left abdominal aorta and iliac artery were patent.After treatment, the patient was discharged on (b)(6) 2021.
Event or Problem Description
The patient recovered and discharged from the hospital.The results of follow-up were good.The physician did not complain about gore's products.
Additional Manufacturer Narrative
Update g1 and g3.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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; 890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12966023
• Report Number: 3007284313-2021-01699
• Device Sequence Number: 11866183
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: PLC121400
• Device Catalogue Number: PLC121400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 05/17/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/16/2021; 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG