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

Model Number	G48423
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).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
It was reported that during an evar procedure, the suprarenal stent[s] of a zenith flex aaa endovascular graft bifurcated main body would not release.The device was deployed over a cook wire guide.The physician then went to release the top cap to open the suprarenal stent[s] but found it to be "stuck".Methods including pushing the grey positioner forward and using a balloon to "keep everything stable" were attempted but unsuccessful in assisting in moving the top cap.The trigger wire was released without issue.As a result, the surgery was converted to an open procedure to remove the device and manage the patient's aaa.The patient was said to have been unsuitable for open procedure and passed two days later.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation: (b)(6) informed cook of an incident involving a zenith flex aaa endovascular graft bifurcated main body, rpn: tffb-30-96-zt from lot: 9782495.It was reported that the top cap could not be advanced off the suprarenal stent during the procedure.The device was explanted and the procedure was converted to open aneurysm repair.The patient was not fit for open repair and died two days after the procedure.As reported, the device was advanced and deployed over a lunderquist wire guide.When the user tried to advance the top cap to open the suprarenal stents, it would not release and got stuck.The gray positioner was advanced forward and a coda balloon was inflated to keep the graft stable but the top cap could not be advanced forward.The proximal trigger wire was released without issue.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and dimensional verification of the returned device, was conducted during the investigation.One used tffb delivery system with the graft fully deployed was returned to cook for evaluation.Upon visual inspection, the barbs on the top stent and graft body had no visible damage.The dilator tip was curved at the distal end.Biomatter was noted throughout the device components and graft.The delivery system was bent in a "u" shape.A wire guide protruded proximally from the cannula hub and the sheath was withdrawn just distal to the trigger shaft.The inner cannula was cut below the bottom cap, separating the remaining cannula length, top cap, and dilator dip.Trigger wires and release mechanisms were not returned.The bottom cap was deformed with a small portion of inner cannula visible from the distal end.Scratch markers consistent with hemostat use were visible on the bottom cap/distal gray pusher and the outside of the top cap.The exposed length of inner cannula proximal to the top cap was bent.The pin vise was unlocked upon device return.Difficulty was experienced advancing the inner cannula.Increased force was applied to the inner cannula, allowing it to be advanced until the black cannula hub met the pin vise.The deformation on the bottom cap resolved once the bent portion of the inner cannula was advanced.The top cap was cut circumferentially and longitudinally, revealing no significant damage or scratches on the inside.A indentation on the proximal portion of the top cap was observed and is consistent with normal indentation from the proximal trigger wire.Measurements of appropriate device components were found to be within manufacturing tolerance.Damage to the delivery system was consistent with open explantation of the device.Evaluation of the device did not identify any contributing factors for difficulty advancing the top cap during the procedure.Cook has concluded that the device was manufactured to specification.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (9782495) and the related subassembly lots revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.It should be noted that tffb devices are distributed via one-device lots.As there are no related non-conformances, adequate inspection activities in place, objective evidence that the dhr was fully executed, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product instructions for use (ifu), [t_zaaaf_rev5] ¿zenith flex® aaa endovascular 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 flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems,¿ non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: with a length of at least 15 mm, with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, with an angle less than 60 degrees relative to the long axis of the aneurysm, and with an angle less than 45 degrees relative to the suprarenal aorta.Iliac artery distal fixation site greater than 10 mm in length and 7.5 to 20 mm in diameter (measured outer wall to outer wall).4 warnings and precautions 4.2 patient selection, treatment and follow-up 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 neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.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.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.4.5 implant procedure the zenith flex aaa endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.Do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.To avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all component 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.Inadequate fixation of the zenith flex aaa endovascular graft may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.Maintain wire guide position during delivery system insertion.Before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.5 adverse effects 5.2 potential adverse effects adverse events that may occur and/or require intervention include, but are not limited to: endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion surgical conversion to open repair 11 directions for use 11.1 bifurcated system 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.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 main body until the top stent is fully deployed.(figs.15 and 16) advance the top cap cannula an additional 1 to 2 cm and then retighten the pin vise to avoid contact with the deployed suprarenal stent.Note: if unable to fully deploy suprarenal stent by advancing the top cap inner cannula, see section 14.2, suprarenal stent deployment troubleshooting.14 troubleshooting 14.2 suprarenal stent deployment troubleshooting caution: the following steps should be performed only if unable to deploy the suprarenal stent as described in section 11.1.7.1.If the suprarenal stent cannot be fully deployed by advancing the top cap inner cannula, advance a molding balloon through the contralateral limb of the main body and position it just superior to the bifurcation of the stent graft.2.To add support to the inner cannula, inflate the balloon to the full diameter of the graft.3.Loosen the pin vise.(fig.14).4.Stabilize the gray positioner and balloon catheter, and advance the inner cannula to deploy the suprarenal stent.If the suprarenal stent is fully deployed: 5.Tighten the pin vise; deflate and withdraw the balloon.6.Advance the contralateral wire guide into the thoracic aorta and return to the appropriate step in the instructions for use to complete the procedure.If still unable to fully deploy the suprarenal stent: 5.Tighten the pin vise and deflate the balloon.While maintaining balloon position, stabilize the gray positioner and withdraw the sheath to fully deploy the ipsilateral limb.6.Remove the safety lock from the ipsilateral limb trigger-wire release mechanism.7.Withdraw and remove the trigger-wire by sliding the ipsilateral limb trigger-wire release mechanism off the handle, and remove via its slot over the device inner cannula.8.Loosen the pin vise (fig.22) and, while maintaining inner cannula position, advance the gray positioner and sheath into the graft until the tip of the gray positioner is approximately 2 cm inferior to the proximal gold markers.(fig.46) the advanced gray positioner provides added support to the inner cannula.Note: take care not to advance the graft during gray positioner and sheath advancement.Note: ensure that the tip of the gray positioner is not advanced into the top cap.9.Lock the pin vise.10.Verify position of the gold markers inferior to the renal arteries.11.Reposition molding balloon so that it is seated against the bifurcation.12.Inflate the balloon to the full diameter of the graft.(fig.37) 13.Loosen the pin vise.14.Stabilize the gray positioner and balloon catheter, and advance the inner cannula to deploy the suprarenal stent.15.Tighten the pin vise.16.Deflate the balloon and advance the contralateral wire guide into the thoracic aorta.Note: due to early ipsilateral leg deployment and trigger-wire release, it is suggested to leave the molding balloon in or just above the contralateral limb for use in graft stabilization during placement of the ipsilateral limb.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event was unable to be established.Given the available information, there is no evidence suggesting the user deployed the graft outside of ifu recommendations.Patient anatomical features (i.E.Tortuous iliac arteries and aneurysm neck angulation) can decrease the centerline force to the top cap when advancing the inner cannula; however, this cannot be confirmed without additional information or imaging.It should also be noted that proper orientation and collapse of the suprarenal stent within the top cap could not be determined as the graft was fully deployed upon return.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10869060
• Report Number: 1820334-2020-02156
• Device Sequence Number: 11422070
• Product Code: MIH
• UDI-Device Identifier: 10827002484235
• UDI-Public: (01)10827002484235(17)210613(10)9782495
• Combination Product (Y/N): N
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2021
• Device Model Number: G48423
• Device Catalogue Number: TFFB-30-96-ZT
• Device Lot Number: 9782495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CODA BALLOON; LUNDERQUIST WIRE; CODA BALLOON; LUNDERQUIST WIRE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR