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

Model Number	PXC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A trunk-ipsilateral leg endoprosthesis (rlt281216 on the right side) and a contralateral leg endoprosthesis (pxc121200 on the left side) were implanted.As reported, the patient had yearly non-contrast computed tomography scans.In (b)(6) 2021, the follow up ct showed a summary of "stable graft position".The physician reported that he did not have another encounter with patient until late (b)(6) 2021, when the patient complained of increasing claudication.The patient indicated that he had been seeing a primary care physician for the last two years, complaining of leg and back pain.The patient did have several tests including x-ray of the knee, x-ray of lumbar spine and emts.The patient reported that he did not see the patient until the end of (b)(6) 2021 with the above-mentioned claudication, at which time doppler of the lower extremity was performed.The test came back abnormal.On (b)(6) 2022, a cta of the abdomen and pelvis was performed which showed a thrombosed contralateral leg endoprosthesis in the left common iliac.There was no stenosis of the graft nor graft collapse.The physician reported that distal to the graft there was progressive high-grade stenosis of the distal common iliac which extended to the iliac bifurcation.The physician reported that the thrombosed contralateral leg endoprosthesis event happened well distal to the stent graft, most likely because of the high-grade stenosis below the graft due to increased atherosclerosis of the distal common iliac.On (b)(6) 2022, the physician performed an angiogram which supported the cta finding of (b)(6) 2022, of a thrombosed contralateral leg endoprosthesis.After consulting with the gore field sales associate regarding options, the physician electively decided to treat patient with tissue plasminogen activator (tpa) after placing a catheter into thrombosed iliac.The physician reported that during the overnight on (b)(6) 2022, the patient pulled his tpa catheter.Based upon the catheter being removed by the patient and the appearance of the left lower extremity, the patient was transferred to ruby memorial hospital under the care of dr.Maxwell almenoff.The patient was taken to the operating room, where a thrombectomy was attempted.However, the physician found the limb to be unsalvageable.An open amputation thru the knee joint was then performed.On monday, (b)(6) 2022, the patient was seen by dr.(b)(6) for a hip disarticulation as the limb was unsalvageable above the original amputation.As last reported to gore, the patient is in critical care at (b)(6) hospital.It is unknown if the patient was covid-19 positive or had any other conditions that might have led to the formation of the thrombosis.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13667504
• Report Number: 2953161-2022-01126
• Device Sequence Number: 4893686
• Product Code: MIH
• UDI-Device Identifier: 00733132609925
• UDI-Public: 00733132609925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 05/31/2018
• Device Model Number: PXC121200
• Device Catalogue Number: PXC121200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/04/2022
• Date Device Manufactured: 06/04/2015
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male