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 Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): phone: (b)(6).Fax: (b)(6).Postal code: (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 an (b)(6) patient had a zenith flex aaa endovascular graft bifurcated main body implanted "recently" for an endovascular aneurysm repair (evar) and iliac brand-graft device (ibd) procedure.The physician reported there is what he believes to be a type iii endoleak above the graft bifurcation, however the exact location of the leak is difficult to identify on the ct scan.An additional procedure was completed by inserting two 12 mm pta balloons into the limbs of the flex graft.Angiography revealed a leak in the body of the graft.A procedure to reline using a body extension graft is being discussed but has currently not been scheduled.No other adverse effects were reported.
Additional Manufacturer Narrative
Investigation - evaluation: on 23apr2021, cook became aware of an incident where a zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-32-96-zt, lot: 13193948) experienced an endoleak.The physician plans to realign the graft.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a single postop ct study was provided to cook and submitted for expert image review.The reviewer notes that there is a large endoleak surrounding the main body graft from the proximal aaa sac extending distally into the mid right common iliac artery (cia) sac.The size/appearance of the endoleak suggests a type 3b defect of the device between the proximal segment and the flow divider, though this cannot be confirmed without additional imaging.Intermittent areas of focal, dense calcification of the aortic wall at the proximal neck junction and along the aaa sac adjacent to the endograft are present, which may have contributed to the possible graft defect.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 (13193948) and the related graft subassembly lot revealed no recorded nonconformances.It should be noted that tffb- devices are distributed via one device lots, giving no indication of nonconforming product in house.A database search did not identify any other events associated with the reported device lot.As there are adequate inspection activities in place, there is objective evidence that the dhr was fully executed, there are no related non-conformances, and no other lot-related complaints have been received from the field, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The current 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: ¿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.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 requirements 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.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.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: appropriate procedural imaging is required to successfully position the zenith flex aaa endovascular graft and assure accurate apposition to the aortic wall.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.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.5 adverse events: 5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture, and death.Endoleak.Endoprosthesis: improper component placement; component migration.8 patient counseling information: the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture, and death.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.11.1 bifurcated system 11.1.12 molding balloon insertion.5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.Final angiogram 1.Position angiographic catheter just above the levels of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.12 imaging guidelines and postoperative follow-up 12.1 general: the long-term performance of endovascular grafts with secondary endovascular intervention using additional components has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient.The minimum requirements for patient follow-up (described in the instructions for use for the zenith flex aaa endovascular graft) should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak¿.Based on the information provided, review of imaging, and results of our investigation, a potential root cause was not traced to the device, but rather the patient's condition.The image reviewer noted that there are intermittent areas of focal, dense calcification of the aortic wall at the proximal neck junction and along the aaa sac adjacent to the endograft, which potentially contributed to the failure.Additionally, endoleaks are a known inherent risk of using this device.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.
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
• 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: 11783100
• Report Number: 1820334-2021-01298
• Device Sequence Number: 847623
• Product Code: MIH
• UDI-Device Identifier: 10827002484280
• UDI-Public: (01)10827002484280(17)220527(10)13193948
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 05/27/2022
• Device Model Number: N/A
• Device Catalogue Number: TFFB-32-96-ZT
• Device Lot Number: 13193948
• 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: 04/23/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male