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	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty was experienced when attempting to advance a zenith flex with spiral-z technology aaa endovascular graft iliac leg over a lunderquist wire during a fenestrated endovascular aortic repair (fevar) procedure on a male patient with both vessel calcification and tortuosity.When trying to track the device over the wire outside of the patient, it was noted that the wire would not advance more than 5cm into the delivery system.The device was not implanted.The physician used another similar device, that successfully advanced over the wire, to complete the procedure.No harm to the patient has been reported.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
It should be noted that zsle- devices are distributed via one-device lots.Initial reporter occupation: lead tech.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Mh mission hospital lllp informed cook on 13apr2022 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-74-zt, lot: 14578336).The device failed to track over the lunderquist wire guide.The site stated the wire guide could not advance more than 5cm into the delivery system.The device was replaced with zsle-16-56-zt that was able to track over the same wire guide.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One prior to use zsle-16-74-zt was returned for evaluation.A 0.035¿ wire guide was inserted through the cannula hub of the delivery system, in which resistance was noted at 28cm.The wire guide was then inserted through the distal tip and could only be advanced 7.1cm.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14578336 and the delivery system subassembly lot sa14404515 found no nonconformances that could have contributed to the reported failure mode.The thread cannula subassembly lot sa14402045 found one nonconformances unrelated to the failure.It should be noted that there were no other complaints associated with the reported lot number.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev4 ¿zenith spiral-z aaa iliac leg with the z-track introduction system,¿ provides the following information to the user related to the reported failure mode: how supplied: the product is sterile if the package is unopened and undamaged.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.Store in a cool, dry place.10 clinical use information: 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.Evidence provided by the complaint facility, dhr, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure could not be established.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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.

• 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: 14244450
• Report Number: 1820334-2022-00668
• Device Sequence Number: 5016073
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)250308(10)14578336
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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: 03/08/2025
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 14578336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LUNDERQUIST WIRE
• Patient Sex: Male
• Patient Weight: 61 KG