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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: h6 (additional annex a code).Investigation ¿ evaluation.While observing a procedure at william p clements jr university hospital, dallas, texas, the cook sales representative observed the top cap of the delivery system of a zenith renu aaa ancillary graft converter dragging the graft down when the delivery system was removed.The patient was a 57-year-old female who was hospitalized at the time of the event.She had undergone a previous surgical repair with a sewn-in graft and had experienced an occlusion in the right common iliac artery on an unknown date.She underwent an endovascular aortic repair (evar) on 20dec2022 to place a zenith renu aaa ancillary graft converter (rpn: ax1-2-22-113-zt, lot 13563419).The diameter of the access site was 7.9 mm.The top cap of the delivery system was able to be docked, but the physician experienced difficulty advancing the grey positioner.This was reported due to patient anatomy.The infrarenal neck anatomy was described as severely angled.While removing the delivery system, the top cap dragged the graft down.Angiography appeared to show that there was also a tear in the graft fabric.Two gore endovascular cuffs were placed during the procedure to seal the tear in the zenith renu aaa ancillary graft converter (rpn: ax1-2-22-113-zt, lot 13563419).Reviews of 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 as it remains within the patient; therefore, no physical examinations could be performed.However, intraoperative imaging in the form of static images was provided to cinc by the cook sales representative for the investigation.An image review was completed by a cook global product manager and her team.The review of the imaging indicated that it appears the patient originally underwent evar with competitor's endografts in their native aorta.The competitor's system likely migrated downward due to tortuous anatomy,.However, an original ct scan prior to open repair was not provided to confirm.The competitor's systems also lack the active fixation that cook grafts have that assist in combating downward migration of the graft.In a secondary procedure, the surgeon performed open repair.The native aorta was bypassed.The saccular aneurysm visible in the images provided appears to have grown proximal to the synthetic graft material.The reviewer suspected that this location was where the synthetic graft was sutured.The cook ax1 was placed inside the synthetic surgical graft, not the native vessel where the original competitor's grafts were located.The vessel angulation and the suture site may have contributed to the difficulty deploying the graft.The reviewer stated that if the physician was able to track the graft to the proper deployment location, there may have been too much tension to deploy the graft easily.Alternatively stated, the grey positioner and inner cannula had to track through several sharp angles to arrive at the deployment site.A bend was noted in the delivery system after removal.The patient's anatomy was within cook graft exclusion criteria.The image reviewer also noted that the second internal seal stent on the ax1 separated from the first internal seal stent, meaning it tore.After separating, the second internal seal stent ¿accordioned,¿ and overlapped with the first external seal stent below.The reviewer is unsure if the tear was circumferential or a partial tear between the first and second internal seal stents.A competitor's cuff was placed to close the gap.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 13563419 and the 18 fr main body delivery system subassembly lot sa13386276 recorded no non-conformances related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.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 previously 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.4 warnings and precautions 4.2 patient selection, treatment and follow-up ¿ the zenith renu aaa main body extension may be used when all of the following apply: ¿ pre-existing graft is not composed of ptfe graft material.¿ length from the lowest renal artery to the bifurcation of the pre-existing graft is >43mm (refer to section 10.5 for specific device sizing guidelines), and ¿ distal fixation site (within the pre-existing graft body) is =34 mm in diameter and at least on cook-z stent in length, with more overlap length being preferred.¿ use of the zenith renu aaa converter with an iliac leg graft may be considered when the distal fixation site (arterial) is 7.5 to 20 mm in diameter (measured outer wall to outer wall) and >10 mm in length, with 20 to 30 mm being preferred.¿ 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.The safety and effectiveness of the zenith renu aaa ancillary components with the z-trak introductions system have not been evaluated in the following patient populations: ¿ less than 15 mm in length or greater than 60 degrees angulation of the proximal aortic neck relative to the long axis of the aneurysm.¿ a neck diameter measured outer wall to outer wall greater than 32 mm and less than 18 mm ¿ iliac distal fixation site less than 10 mm in length and less than 7.5 mm and greater than 20 mm in diameter (measured outer wall to outer wall) 4.4 device selection strict adherence to the zenith renu aaa ancillary graft ifu sizing guide is strongly recommended when selection the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated fracture, migration, device infolding or compression.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.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ 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.¿ 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.¿ the zenith renu aaa ancillary graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.5 potential adverse events.Adverse events that may occur and/or require intervention include, but are not limited to: ¿ 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.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).5.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.6.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.7.Ensure the captor hemostatic valve on the flexor introducer sheath is turned to the open position.8.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 9.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 note: the proximal stent is secured within the top cap by a trigger-wire 1.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:t o ensure patency of renal arteries, recognize that the proximal graft markers are 2 mm below the proximal edge of the graft material caution: during proximal trigger-wire removal, top cap advancement, and subsequent suprarenal stent deployment, verify that the position of the main body extension wire guide extends just distal to the aortic arch and the 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 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.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 main body.B.Retighten the pin vise c.Remove the top stent trigger-wire release mechanism 3.Loosen the pin vise.(fig.12) control the position of the graft by stabilizing the gray positioner of the introducer.4.Deploy the suprarenal stent by advancing the top cap inner cannula 1 to 2 mm at a time while controlling the position of the device until the top stent is fully deployed.(figs.13 and 14).11.1.5 zenith renu aaa main body extension distal (bottom) deployment note: the distal stent is still secured by the trigger-wire 1.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.1.Loosen pin vise.2.Secure sheath and inner cannula to avoid any movement of these components 3.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.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.Note: maintain position of sheath and wire guide 5.Close the captor hemostatic valve on the flexor introducer sheath by turning it in a clockwise direction until it stops.12.1 general.¿ the zenith renu aaa ancillary graft is not intended for primary endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms.It is intended for use in patients in whom an endovascular graft has already been placed.Evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents 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, reviews of customer provided imaging, and the results of the investigation, cook was unable to establish a definitive cause for the failure mode.However, with the difficulties experienced during the deployment it is feasible to suggest that patient anatomy and the procedure itself contributed to 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.
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