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

Model Number	G32550
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device was oriented on top of the patient with all markers successfully identified.The graft was loaded and advanced with no issues.Then, due to anatomical tortuosity, the device became inverted.They proceeded to correct the inversion by rotating the graft, causing tension and pressure on the trigger wires and graft.The procedure continued per the instructions for use (ifu) supplied with the device.There was no issue unsheathing and no issue cannulating the renals through the fenestrations.When it was time to finish deployment of the graft and remove the trigger wires, the corkscrew tension on the delivery system and trigger wires made it very difficult to remove the first two trigger wires.When attempting to remove the third and final distal trigger wire; the wire broke at the point of the attachment to the trigger wire release mechanism.At this point the graft was still attached via the trigger wire distally.They were unable to locate, grab or visualize the other end of the trigger wire near the delivery handle.The white delivery handle components were disassembled; and they attached a hemostat to the handle end of the trigger wire and carefully pulled, with much force, thus freeing the graft distally from the delivery system.From there they were able to dock the top cap and remove the entire delivery system without further issue.The rest of the procedure was per ifu and without issue.The final run was satisfactory with proper seal and vessel profusion.
Additional Manufacturer Narrative
The graft remains implanted in the patient and the delivery system was disposed of by the customer.No part of the device was returned for evaluation.No images were received to assist the investigation.The work order for lot number ac1091712 was reviewed and appears complete and correct, with no evidence that a device non-conformance or deficiency contributed to the reported event.Review of specifications found that a defective product would likely be detected prior to distribution.The instructions for use (ifu) supplied with the device provides instructions for the correct deployment of the graft and lists improper component placement and incomplete component deployment as potential adverse events.The ifu also provides guidance for proper patient selection, stating "access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 14 french to 22 french vascular introducer sheaths.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization/trauma".The mandatory requirement to always review the complaint history, during a complaint investigation, will ensure that trends are constantly monitored.Based on the information available, a definitive root cause could not be established.It is possible that one or more of the following factors may have contributed to the difficulties experienced during the procedure: twisting of device whilst advancing into target deployment area, wire entanglement within the system, tortuosity in trigger wire path within the delivery system, procedural factors, patient factors.
Event or Problem Description
The device was oriented on top of the patient with all markers successfully identified.The graft was loaded and advanced with no issues.Then, due to anatomical tortuosity, the device became inverted.They proceeded to correct the inversion by rotating the graft, causing tension and pressure on the trigger wires and graft.The procedure continued per the instructions for use (ifu) supplied with the device.There was no issue unsheathing and no issue cannulating the renals through the fenestrations.When it was time to finish deployment of the graft and remove the trigger wires, the corkscrew tension on the delivery system and trigger wires made it very difficult to remove the first two trigger wires.When attempting to remove the third and final distal trigger wire; the wire broke at the point of the attachment to the trigger wire release mechanism.At this point the graft was still attached via the trigger wire distally.They were unable to locate , grab or visualize the other end of the trigger wire near the delivery handle.The white delivery handle components were disassembled; and they attached a hemostat to the handle end of the trigger wire and carefully pulled, with much force, thus freeing the graft distally from the delivery system.From there they were able to dock the top cap and remove the entire delivery system without further issue.The rest of the procedure was per ifu and without issue.The final run was satisfactory with proper seal and vessel profusion.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 13529750
• Report Number: 9680654-2022-00002
• Device Sequence Number: 20031754
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)241130(10)AC1091712
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: G32550
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Device Lot Number: AC1091712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male