MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32592
Health Effect - Clinical Code	Occlusion (1984)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with a pre-existing endograft placed at another facility had come in with a total limb occlusion due to thrombus.Physician lysed thrombus and stented iliac limb.Patient is doing well.The limb occlusion caused the patient to be symptomatic.
Additional Manufacturer Narrative
The device was not returned for evaluation.The imaging associate with the complaint was reviewed and reveal the iliacs to be fairly tortuous.Medical director who reviewed the imaging stated "i can¿t see any failure or fault with the zfen device or its other components, and the thrombosis may have been due to the manipulation of the device through the left iliac, or due to patient related factors such as hypercoagulability etc.We don¿t have information on whether or not the patient had been taking anti-platelet medications prior to the occlusion." the work order ac1036826 was reviewed and appears complete and correct.The ifu sent with the complaint device lists arterial or venous thrombosis as a potential adverse event and states that "the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up." based on the information received, it is difficult to determine an exact root cause.One or more of the following factors may have contributed to the complaint: rough surface prone to thrombus formation.Inadequate medication of patient with anticoagulants.Patient/procedural factors.
Event or Problem Description
A patient with a pre-existing endograft placed at another facility had come in with a total limb occlusion due to thrombus.Physician lysed thrombus and stented iliac limb.Patient is doing well.The limb occlusion caused the patient to be symptomatic.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 9820969
• Report Number: 9680654-2020-00013
• Device Sequence Number: 16468726
• Product Code: MIH
• UDI-Device Identifier: 10827002325927
• UDI-Public: (01)10827002325927(17)220507(10)AC1036826
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 05/07/2022
• Device Model Number: G32592
• Device Catalogue Number: ZFEN-D-16-62-76-C
• Device Lot Number: AC1036826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR