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	G32554
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a clot that formed in the overlap of the device and of a second device.A covered vbx stent was placed to flatten the clot and open up the limb a bit.
Event or Problem Description
There was a clot that formed in the overlap of the device and of a second device.A covered vbx stent was placed to flatten the clot and open up the limb a bit.
Additional Manufacturer Narrative
No product was received for evaluation.No images were available to assist the investigation.The work order was reviewed and appears complete and correct.Additional information was received which clarified that 1) the patient was not on any medication following initial placement of the grafts.2) following placement of the vbx device, the patient will be on anticoagulants for 6 months.3) the identity of the anticoagulant medication was not provided.It was later confirmed that the patient was not on any kind of anti-platelet medication.Based on this information, the medical director stated: "[anti-platelet medication:] they are the most important, and lack of those would be by far the most likely cause of thrombus formation.Anticoagulation medication does not stop platelet aggregation in response to a foreign body¿s presence (i.E., the device).If they were not on anti-platelet medication, either during and/or after the original procedure, then the thrombus formation is no surprise.It is a normal physiological response to the presence of a foreign body, in this case, the endovascular device.The thrombus formation was most likely due to platelet aggregation, due in turn to the lack of anti-platelet medications.It was almost certainly not due to any fault or failure of the device itself." the instruction for use (ifu) supplied with this device states: "systemic anticoagulation should be used during the implantation procedure based on hospital and physician preferred protocol" and "refer to institutional protocols relating to anesthesia, anticoagulation and monitoring of vital signs." based on the available information, the most likely cause of the thrombus forming between the devices was due to platelet aggregation in response to the presence of the endovascular device, due to the patient not being on anti-platelet medication pre, during, and after the procedure.

• 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: 12014266
• Report Number: 9680654-2021-00012
• Device Sequence Number: 3425583
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)221113(10)AC1049145
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1049145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/06/2021
• 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: 75 YR