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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that an unknown zenith flex aaa endovascular graft bifurcated main body migrated during an endovascular abdominal aortic repair procedure on an 83-year-old male patient.The device was placed in the patient to treat a lower abdominal aortic aneurysm of the renal artery.A post-operative type 1a endoleak remained due to calcification and a kink in the proximal neck.Additional treatment for the type 1a aneurysm was performed six months after the index procedure.The physician planned for the placement of an additional stent graft on the proximal side, with bilateral renal artery reconstruction.A fenestration was made in the zenith flex aaa endovascular graft bifurcated main body for the right renal artery.Usage of the chimney technique for the left renal artery was planned.There was concern that the limbs of the main body graft would cause trouble when placing it in the existing zenith alpha abdominal, so the limbs were cut after the fenestration was made.The main body was deployed into the target site; however, there was no distal fixation of the main body.When the top cap opened, the graft slipped to the proximal side and migrated to the position of the superior mesenteric artery.Ultimately, the bilateral renal arteries and the superior mesenteric arteries were bailed out using the triple chimney method.No other harm to the patient has been reported at this time.The information provided to cook was obtained from an abstract for japan endovascular treatment conference 2023 that began on (b)(6) 2023.This report captures zenith flex aaa endovascular graft bifurcated main body migration following alteration and deployment.
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
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 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 or that a death or serious injury occurred; nor is it admission 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.
Additional Manufacturer Narrative
Investigation ¿ evaluation: information was provided to cook on 25may2023 in the abstract of jet2023 (japan enodvascular treatment conference 2023) of an incident involving a zenith flex aaa endovascular graft bifurcated main body (tffb-26-82-zt) lot 9840240.On (b)(6) 2020 at (b)(6) hospital an 83-year-old male patient underwent an evar (endovascular aneurysm repair) procedure.The following devices were placed zimb-26-118, a zisl-20-77 placed on the left and a zisl-20-59 placed on the right.Postoperatively a type 1a endoleak remained.Per the site this was due to calcification and a kink of the proximal neck.Additional treatment was performed six months after the procedure.The endoleak was treated with placement of a stent graft on the proximal side with bilateral renal artery reconstruction.The physician was concerned the limbs of the tffb main body would cause trouble when placing the device in the existing zimb.Therefore, it was decided to cut the limbs off.The device was deployed at the target site, however because there was no distal fixation of the tffb when the top cap was opened, the graft slipped to the proximal side and migrated to the position of the superior mesenteric artery.The bilateral renal arteries and the superior mesenteric arteries were bailed out using the triple chimney method.Mdr # 1820334-2023-00681 focused on the migration of the device.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned for investigation; therefore, no physical examination could be conducted.However, medical imaging was provided by the customer for expert review.It was noted that at 5 months postop, there was a type 1a endoleak around the proximal main body graft extending into the proximal aaa sac.This is most likely due to hostile neck anatomy with only 10 mm of proximal graft wall apposition between the lra and the proximal aaa sac and a significant 65-degree angulation of the graft between the 1st and 2nd stent segments at the infrarenal neck junction.Though preop imaging is not provided to confirm this anatomy prior to repair, the proximal neck anatomy is most likely outside the ifu for this device.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 9840240 and the related subassembly lots revealed no related non-conformances.A database search was completed and found no other complaints for this lot number.Evidence provided by the complaint facility, device failure analysis, device history record, 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.Cook also reviewed product labeling.The product ifu, t_zaaaf_rev 4 ¿zenith flex aaa endovascular graft with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: 1 device description.1.1 aortic main body and iliac leg components.The zenith flex aaa endovascular graft is a modular system consisting of three components, a bifurcated aortic main body and two iliac legs.The graft modules are constructed of full-thickness woven polyester fabric sewn to self-expanding stainless-steel cook-z stents with braided polyester and monofilament polypropylene suture.The modules are fully stented to provide stability and the expansible force necessary to open the lumen of the graft during deployment.Additionally, the cook-z stents provide the necessary attachment and seal of the graft to the vessel wall.The bare suprarenal stent at the proximal end of the graft contains barbs that are placed at 3 mm increments for additional fixation of the device.To facilitate fluoroscopic visualization of the stent graft, gold radiopaque markers are positioned as follows: one on the lateral aspect of the most distal stent on the contralateral limb of the bifurcated section of the main body and four in a circumferential orientation within 2mm of the most superior aspect of the graft material.2 indications for use.The zenith flex aaa endovascular graft with the h&l-b one-shot introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac 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 than18 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 axis of the suprarenal aorta.Iliac artery distal fixation site of greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall).4 warnings and precautions.4.1 general.Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up.The zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.Iliac artery distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.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.Adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 16 french 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.Diameters.Utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.The contrast-enhanced spiral ct scan must start 1 cm superior to the celiac axis and continue through the femoral heads at an axial thickness slice of 3 mm or less.4.4 device selection.Strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.4.5 implant procedure.Inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular 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.5.2 potential adverse events.Adverse events that may occur and/or require intervention include, but are not limited to: endoleak.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 6.5 endoleak management.During the clinical study type i endoleaks were treated during the initial procedure by use of additional balloon seating or if unsuccessful, additional prostheses.7 patient selection and treatment.7.1 individualization of treatment.The risks and benefits should be carefully considered for each patient before use of the zenith flex aaa endovascular graft.Additional considerations for patient selection include but are not limited to: patient's anatomical suitability for endovascular repair.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 axis of 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) freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft the final treatment decision is at the discretion of the physician and patient.10.5 device sizing guidelines the choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.11 directions for use anatomical requirements proximal aortic neck lengths should be a minimum of 15 mm with a diameter measured outer wall to outer wall of 18 ¿ 32 mm.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the main body system (i.E., define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm, and iliac arteries.3.Quality of the aortic neck.4.Diameters of infrarenal aortic neck and distal iliac arteries.5.Distance from renal arteries to the aortic bifurcation.6.Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).7.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.8.Consider the degree of vascular calcification.Based on the information provided, expert review of medical imaging provided by the facility, and the results of our investigation, cook has determined reasonably foreseeable misuse as a cause for the failure mode.The device was placed as intervention for a type 1a endoleak.The physician was concerned the limbs of the tffb main body would cause trouble when placing the device in the existing zimb.Therefore, it was decided to cut the limbs off.The device was deployed at the target site, however because there was no distal fixation of the tffb when the top cap was opened, the graft slipped to the proximal side and migrated to the position of the superior mesenteric artery.In addition to this it was noted in the imaging in the linked complaint the neck anatomy was hostile with only 10 mm of proximal graft wall apposition between the lra and the proximal aaa sac and a significant 65-degree angulation of the graft between the 1st and 2nd stent segments at the infrarenal neck junction.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
• 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: 17040324
• Report Number: 1820334-2023-00681
• Device Sequence Number: 15056102
• Product Code: MIH
• UDI-Device Identifier: 10827002484129
• UDI-Public: (01)10827002484129(17)210706(10)9840240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 07/06/2021
• Device Model Number: N/A
• Device Catalogue Number: TFFB-26-82-ZT
• Device Lot Number: 9840240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 08/24/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/07/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2019
• 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
• Patient Age: 83 YR
• Patient Sex: Male