MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

Only the delivery system of the device will be returned.The stent remains in the patient.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

A patient underwent a procedure where a cook zenith renu aaa ancillary graft converter was used.The physician reported difficulty when attempting to remove the device.This difficulty led to slight migration of the graft.Additionally, when the physician was removing the dilator from the delivery sheath, the hemostatic valve fell apart, completely.The procedure was able to be completed.It was reported that the physician was happy with the overall result.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information was provided on 04nov2022 indicating that use of the zenith renu aaa ancillary graft converter was a primary intervention.Also, the peel away sheath of the delivery system had been removed.No other adverse effects were reported for this incident.

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 received on 18oct2022 about the cook zenith renu aaa ancillary graft converter used during a procedure for a patient with the pre-existing condition of an angled neck.The physician was able to originally land the device in the planned target zone; however, the graft migrated and the fabric partially covered the left renal artery.In return, an additional procedure was performed of stenting the left renal artery.The angulation of the aneurysm neck relative to the suprarenal aorta as well as the long axis of the aaa was angled but the exact angle was unknown.The delivery system was rotated per ifu.However, the alternative trigger wire release method was not utilized as per labeling.A 32 coda balloon (unavailable lot number) was used during the procedure.No other adverse effects were reported for this incident.

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

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

Manufacturer Narrative

Investigation ¿ evaluation: a representative from (b)(6) reported a difficulty with the zenith renu graft and reported it felt stuck which then caused an issue with the graft migrating slightly and the hemostatic valve falling apart at removal.The patient had an angled abdominal aortic neck.The angulation of the aneurysm neck relative to the suprarenal aorta as well as the long axis of the aaa was angled but the exact angle was unknown.The zenith renu aaa ancillary graft converter (rpn: ax1-2-30-113-zt, lot number 14229164) was placed during a primary intervention.The delivery system of the zenith renu aaa ancillary graft converter was rotated per instructions for use (ifu).However, the alternative trigger release method was not utilized per ifu.The physician was able to initially land the device in the planned target zone.However, due to the difficulty when the device got ¿stuck¿ the graft migrated and the fabric portion of the graft covered the left renal artery.When the physician was removing the dilator from the delivery sheath, the captor hemostatic valve fell apart.At an unknown point in the procedure, the peel away sheath was removed from the delivery system.An additional procedure was required to stent the left renal artery.The case was completed, and the physician was happy with the overall end result.The complaint device was examined for two failures, the device feeling "stuck" and the captor hemostatic valve coming apart after the dilator was removed from the delivery sheath.Reviews of documentation including the complaint history, device history record (dhr), drawing, instructions for use, manufacturing instructions, quality control procedures, and specifications, as well as visual inspection of the returned device and unused product, were conducted during the investigation.Only the deployment device was returned in a used condition to cook for evaluation.The device was received with captor valve in pieces.The investigation was completed to record any findings for the device being stuck and causing stent migration.The device was disassembled and not all components were present.There was no damage noted to the threaded tip of the device and no damage was noted to the sheath.The valve control cap for the captor valve was not attached and the iris seal was no longer in the captor valve assembly.The investigators conducted a visual examination to determine if any glue could be seen on the flat surface of the inside of the captor valve or the flanges of the iris valve.There was no evidence of glue noted on the flat surface of the captor valve or the flanges of the iris valve; therefore, the complaint device was determined the device was out of specification.No imaging or planning and sizing was able to be provided for the investigation.Additionally, 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 14229164 revealed no relevant non-conformances.The related subassembly lots for the 18/20fr captor valve assembly, sa13953711 and sa13939522, revealed two relevant non-conformances, "alignment, incorrect" and "failed test, leakage," and subassembly lot for 20fr captor flexor sheath assembly, sa13997761, revealed one relevant non-conformance, "bad flare." the devices for the non-conformances were properly identified, scrapped and the remaining lots were sent to quality control for inspection.Due to the device being out of specification, 203 potentially affected captor valve sub-assemblies lots were reviewed.Eight devices were used for endotoxin testing, three devices were still within cook¿s possession, and no other product complaints were found associated with the remaining lots.Therefore, there is no indication of additional affected product in the field.The three devices within cook's possession were investigated and determined to be within specifications.Cook also reviewed product labeling.The product ifu, t_raaaz_rev2 ¿zenith renu aaa ancillary graft with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: 2 indications for use: the zenith renu aaa ancillary graft with the z-trak introduction system is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms in which there is inadequate proximal fixation or seal with: adequate iliac/femoral access compatible with the required introduction systems, adequate proximal fixation site; with a length from the lowest renal artery to the bifurcation of the previouslay placed endovascular graft of >43mm for the main body extension and >37mm for the converter.With a diameter measured outer wall to outer wall of = 18mm and = 32mm.With an angle <60 degrees relative to the long axis of the aneurysm, and with an angle <45 degrees relative to the axis of the suprarenal aorta.Adequate distal fixation site: for the main body extension, distal fixation site within a graft segment of =34 mm in diameter and one cook-z-stent in length, with more overlap length being preferred.For the converter used in combination with the iliac leg, distal fixation site 7.5 to 20 mm in diameter (measured outer wall to outer wall) and = 10mm in length with 20 to 30 mm being preferred.4 warnings and precautions: key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic sealing length (<15mm); an inverted funnel shape (>10% increase in diameter over 15mm of proximal aortic sealing length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic sealing zone and distal iliac artery interface (if using zenith renu aaa converter device).In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Proximal aortic sealing zones exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.Adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall), morphology (minimal tortuosity, occlusive disease and/or calcification), and pre-existing graft diameter should be compatible with vascular access techniques and delivery system of a 16 to 22 french vascular introducer sheath.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.A vascular conduit technique may be necessary to achieve success in some patients.4.5 implant procedure do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith renu aaa ancillary graft.To avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all components of the system together (from outer sheath to inner cannula).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.Inadvertent partial deployment or migration of the endoprosthesis may require surgical removal.Inaccurate placement and/or incomplete sealing of the zenith renu aaa ancillary graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.Inadequate fixation of the zenith renu aaa ancillary graft may result in increased risk of migration the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.As the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform aniography to check position as necessary.5 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: damage or dislodgement of previously placed graft.Endoprosthesis: improper placement; incomplete deployment; migration; component separation; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.Renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).9 how supplied: 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.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 it to cook.Prior to use, verify correct device(s) (quantity and size) have been supplied for the patient by matching the devices(s) to the order prescribed by the physician for that particular patient.11.1.3 zenith renu aaa main body extension placement: caution: maintain wire guide position during delivery system insertion.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).Advance delivery system until the four gold radiopaque markers are just inferior to the most inferior renal office.Note: to ensure patency of renal arteries, recognize that the proximal graft markers are 2 mm below the proximal edge of the graft material.Repeat the angiogram to verify the four gold radiopaque markers are just inferior to the most inferior renal orifice.Confirm that the position of distal end of zenith renu aaa main body extension will provide at least one cook-z stent (17 or 22mm) overlap in the aortic portion of the pre-existing stent-graft.Ensure the captor hemostatic valve on the flexor introducer sheath is turned to the open position.Use the gripper to stabilize the gray positioner (the shaft of the delivery system) while withdrawing the sheath.Deploy the first covered stent by withdrawing the sheath while monitoring device location.Without moving the table, decrease magnification to check position of the distal end of the device and location of renal arteries.Proceed with deployment until the distal segment of the zenith renu aaa main body extension is fully deployed.Stop withdrawing sheath.11.1.4 zenith renu aaa main body extension proximal (top stent) deployment: perform angiography through an angiographic catheter to verify position of the endovascular graft does not restrict flow to the renal arteries.If necessary, carefully reposition the covered portion of the endovascular graft with respect to the renal arteries.(repositioning can only take place over a small range of distance at this stage).Note: the proximal stent is secured within the top cap by a trigger wire.Remove the safety lock from the top stent trigger-wire release mechanism.Under fluoroscopy, withdrw and remove the trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula 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.11.1.5 zenith renu aaa main body extension distal (bottom) deployment note: the distal stent is still secured by the trigger-wire.Remove the safety lock from the trigger-wire release mechanism.Withdraw and remove the trigger-wire by sliding the trigger-wire release mechanism off the handle and then remove via its slot over the device inner cannula.11.1.6 docking the top cap: loosen pin vise.Secure sheath and inner cannula to avoid any movement of these components.Advance the gray positioner over the inner cannula until it docks with the top cap.Note: if resistance occurs, slightly rotate gray positioner and continue to gently advance.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.Note: maintain position of sheath and wire guide.Close the captor hemostatic valve on the flexor introducer sheath by turning it in a clockwise direction until it stops.Based on the information provided, inspection of the returned device, and the results of the investigation, cook determined a definitive cause for the failure the device got "stuck" could not be established.According to the site angulation of the aneurysm neck relative to the suprarenal aorta as well as the long axis of the aaa was angled but the exact angle was unknown.It is possible that patient condition contributed to this failure mode.However, it cannot be ruled out that the incorrectly assembled hemostatic valve could have contributed to the failure mode though it is unclear how.However, cook determined manufacturing deficiencies contributed to the failure of the captor valve falling apart.When inspecting the complaint device, the presence of glue could not be seen on the flat surface of the captor valve.Therefore, the device was determined to be out of specifications.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 RENU AAA ANCILLARY GRAFT CONVERTER
• 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: 15573338
• MDR Text Key: 307034133
• Report Number: 1820334-2022-01611
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002553825
• UDI-Public: (01)10827002553825(17)240929(10)14229164
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AX1-2-30-113-ZT
• Device Lot Number: 14229164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 11/04/2022; 03/20/2023
• Supplement Dates FDA Received: 10/20/2022; 11/08/2022; 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: 32 CODA BALLOON - MANUFACTURER UNKNOWN
• Patient Outcome(s): Required Intervention