MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55238
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported to cook that zenith flex with spiral-z technology aaa endovascular graft iliac leg would not advance over a guide wire.A patient was undergoing a fenestrated endovascular aortic repair (fevar).A zenith flex with spiral-z technology aaa endovascular graft iliac leg was flushed as normal.When the clinician attempted to advance the graft over the wire, the graft delivery system would not advance.The clinician tried multiple times, rotating and using different angles but the delivery system would not advance.The device was flushed again and the clinician attempted to advance the delivery system again, but the delivery system would not advance over the wire.Another like device was used to complete the procedure without further complications.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d4, d9, h3, h6 (annex a).Investigation ¿ evaluation: it was reported to cook that a zenith flex with spiral-z technology aaa endovascular graft iliac leg would not advance over a guide wire.A patient was undergoing a fenestrated endovascular aortic repair (fevar).A zenith flex with spiral-z technology aaa endovascular graft iliac leg was flushed as normal.When the clinician attempted to advance the graft over another manufacturer's wire, the graft delivery system would not advance.The clinician tried multiple times, rotating and using different angles but the delivery system would not advance.The device was flushed again and the clinician attempted to advance the delivery system again, but the delivery system would not advance over the wire.Another like device was used to complete the procedure without further complications.No adverse effects or additional procedures were reported for the patient.Reviews of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed one related non-conformance in which the device was scrapped.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaasz_rev4.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warnings and precautions: 4.5 implant procedure: ¿ do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith spiral-z aaa iliac leg graft.¿ do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.¿ maintain wire guide position during delivery system insertion.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 cook.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.Based on the information provided, no product returned, and the results of the investigation, cook could not determine a definitive cause for the reported failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19454440
• Report Number: 1820334-2024-00754
• Device Sequence Number: 12553961
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)261009(10)15695098
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: G55238
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 15695098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sex: Unknown