MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported the grey positioner included with the zenith flex aaa endovascular graft bifurcated main body device was difficult to advance to the top cap of the device during an endovascular aortic repair in the abdomen of the patient.After multiple attempts were made to advance the grey positioner, the user used the sheath to help support and advance the grey positioner to connect with the top cap.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received regarding the two cook zenith® spiral-z® aaa iliac leg grafts placed.One iliac leg graft was placed in the left iliac with rpn: zsle-20-74-zt and lot number 15774884.The second iliac leg graft was placed in the right iliac with rpn: zsle-16-56-zt and lot number: 15633211.

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was provided on 18mar2024 indicating that the patient's iliac arteries were not tortuous.As reported, the patient did not have pre-existing conditions or comorbidities.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported the grey positioner included with the zenith flex aaa endovascular graft bifurcated main body device was difficult to advance to the top cap of the device during an endovascular aortic repair in the abdomen of the patient.After multiple attempts were made to advance the grey positioner, the user used the sheath to help support and advance the grey positioner to connect with the top cap.A zenith flex aaa endovascular graft bifurcated main body graft and zenith spiral-z® aaa iliac leg grafts in the left and right iliacs were implanted during the procedure.The patient¿s anatomy was not tortuosity.It is unknown if the patient had any pre-existing conditions or comorbidities in addition to the aaa.The issue did not impact the patient's health or safety.Reviews of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specification 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 dhr for the final product lot revealed no nonconformances.One subassembly lot had two nonconformances reported but they were scrapped prior to further processing.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_zaaaf_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.1.2 main body delivery system the main body graft delivery system uses an 18, 20, or 22 french z-trak introduction system.Dual trigger-wire release mechanisms lock the endovascular graft onto the delivery system until released by the physician.All systems are compatible with a.035-inch wire guide.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 flex aaa endovascular graft.¿ maintain wire guide position during delivery system insertion.¿ 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.¿ as the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary.¿ avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.11 directions for use caution: maintain wire guide position during delivery system insertion.11.1.7 main body proximal (top) deployment caution: during proximal trigger-wire removal, top cap advancement, and subsequent suprarenal stent deployment, verify that the position of the main body wire guide extends just distal to the aortic arch and that support of the system is maximized.2.Remove the safety lock from the top stent trigger-wire release mechanism.Under fluoroscopy, withdraw and remove the trigger-wire by sliding the top stent trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula.(fig.13).If resistance is felt or system bowing is noticed, the trigger-wire is under tension.Excessive force may cause the graft position to be altered.If excessive resistance or delivery system movement is noted, stop and assess the situation.If unable to remove the top stent trigger-wire release mechanism from the top cap, perform the following steps under fluoroscopy: a.Remove tension on the trigger-wire by loosening the pin vise and slightly pulling the inner cannula to move the top cap down over the suprarenal stent.Avoid compressing the zenith flex main body.B.Retighten the pin vise.C.Remove the top stent trigger-wire release mechanism.D.Continue with step 3 in section 11.1.7, main body proximal (top) deployment.11.1.9 main body distal (bottom) deployment 1.Return to the ipsilateral side.2.Fully deploy the ipsilateral limb of the main body by withdrawing the sheath until the most distal stent has expanded.(figs.18 and 20) stop withdrawing sheath.Note: the distal stent is still secured by the trigger-wire.3.Remove the safety lock from the ipsilateral limb trigger-wire release mechanism.Withdraw and remove the trigger-wire by sliding the ipsilateral limb trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula.(fig.21).11.1.10 docking of top cap 4.Retighten the pin vise and withdraw the entire top cap and gray positioner through the graft and through the sheath by pulling on the inner cannula.Leave the sheath and wire guide in place.Based on the information provided, no product returned, and the results of the investigation, cook has determined a definitive cause for the reported failure could not be established.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.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: 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: 18904787
• MDR Text Key: 337731149
• Report Number: 1820334-2024-00344
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484075
• UDI-Public: (01)10827002484075(17)260202(10)15880864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-24-82-ZT
• Device Lot Number: 15880864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 03/26/2024; 05/20/2024
• Supplement Dates FDA Received: 03/25/2024; 03/28/2024; 06/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BENTSON WIRE GUIDE.; LUNDERQUIST WIRE GUIDE.; TWO COOK ZENITH® SPIRAL-Z® AAA ILIAC LEG GRAFTS.; ZSLE-16-56-ZT, LOT: 15633211.; ZSLE-20-74-ZT, LOT: 15774884.
• Patient Age: 77 YR
• Patient Sex: Male