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

Catalog Number	ZFEN-P-2-34-107-R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation could not be performed as the device or photographic evidence of the device was not returned for evaluation.Review of the device history record found the work order for lot ac1182260 appeared complete and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformances raised or temporary deviations in place at the time of manufacture.Review of specifications found that upon reviewing the photos taken of the complaint device during manufacture, it appears that the device was manufactured as per the device order form signed by the physician.However, the loading process occurred after the photos were taken.There are a number of processes and checks in place to ensure that the grafts are loaded in the correct orientation within the delivery system.Review of the instructions for use (ifu) supplied with the device for general information found it to contain appropriate warnings, precautions, and instructions to the user, including: 4.3 implant procedure ¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome ¿ to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).5.Adverse events potential adverse events that may occur and/or require intervention include, but are not limited to: ¿ surgical conversion to open repair 10.2 'inspection prior to use' "inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient".11.4.5 'proximal body placement' "4.Before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers".Caution: maintain wire guide position during delivery system insertions.Caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).There is no evidence to suggest that the user did not follow the instructions for use.A corrective and preventative action (capa) was initiated due to a number of complaints being received for grafts twisted/bunched within the sheath which were identified to be prior to the implant procedure.Images and evaluation of product has identified infolding of the grafts within the sheath, which is most likely occurring during the loading process.Based on the images and evaluation of returned product from previous cases, it has been found that the grafts are likely not being symmetrically compressed, which would not meet manufacturing procedures.These devices are customised to a patient¿s anatomy and are used immediately and not sitting in a warehouse or on a shelf.As per the risk evaluation review, the risk is outweighed by the benefits associated with the use of these devices, and that with the internal actions, manufacture can continue while the capa progresses.Further assessment of risk was determined through a health risk assessment.Although a definitive root cause could not be determined from the investigation; possible cause(s) are: - pin vice undone during loading - graft bunched during loading - graft inadequately compressed during loading an internal action has been taken to address the issue.After considering this event the risk associated with the use of this device is still deemed adequate.Should additional information be received at any time in the future, an additional report may be submitted.
Event or Problem Description
Anterior/posterior markers were not appropriately aligned, ended up deploying the graft more than 30 degrees off: the device was inspected prior to use in order to ensure no damage had occurred.The problem was identified when placing the graft on the patient's abdomen prior to insertion: the anterior/posterior markers were not appropriately aligned within the graft.The markers were off; causing the graft orientation during unsheathing to be off.The markers, when forming the cross, ended up deploying the graft more than 30 degrees off.This was remedied by focusing on where fenestration alignment should be.The procedure was successfully completed with the device in question.No intervention was required.

• 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 4113 ; AU 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• MDR Report Key: 22208510
• Report Number: 9680654-2025-00028
• Device Sequence Number: 6764784
• Product Code: MIH
• UDI-Device Identifier: 10827002325453
• UDI-Public: (01)10827002325453(17)280409(10)AC1182260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2025

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 Catalogue Number: ZFEN-P-2-34-107-R
• Device Lot Number: AC1182260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CAPA-00080
• Patient Sequence Number: 1
• Patient Sex: Male