MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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
In 2014 a patient underwent an endovascular aortic repair (evar) procedure where the following cook grafts were placed: zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt , lot number 4053084) zenith branch endovascular graft iliac bifurcation (rpn: zbis-10-45-41, lot number a937127) zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-56-zt, lot number 4715582) zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt, lot number 4792180) in 2020 a reintervention procedure was completed.The zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt, lot number 4053084) lost wall apposition proximally creating a type 1a endoleak.A fenestrated tube graft (manufacturer unknown) was placed during the secondary procedure.A computed tomography scan was completed on 12apr2023 and an endoleak was noted and thought to be a type 3b endoleak.An ultrasound bubble test was also performed after the reintervention procedure in 2020.On (b)(6) 2023 a reintervention procedure was completed with the intention to reline the distal end of the zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt, lot number 4053084) as it was thought that a fabric tear was present.However, during the procedure it was discovered that the zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt, lot number 4053084) had completely separated from the bridging limb, zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-56-zt, lot number 4715582).A new limb was placed to seal between the zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt, lot number 4053084) and the zenith branch endovascular graft iliac bifurcation (rpn: zbis-10-45-41, lot number a937127) to resolve the endoleak.During expert review of imaging provided for the investigation of events with patient identifier: 406759, a type 1b endoleak was identified on the left zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt, lot number 4792180), which is captured in this report.
Additional Manufacturer Narrative
Investigation-evaluation in 2014 a male patient underwent an endovascular aortic repair (evar) procedure where the following cook grafts were placed: zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt) zenith branch endovascular graft iliac bifurcation (rpn: zbis-10-45-41) zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-56-zt) zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt) in 2020 a reintervention procedure was completed.The zenith flex aaa endovascular graft bifurcated main body (lost wall apposition proximally creating a type 1a endoleak.A fenestrated tube graft (manufacturer unknown) was placed during the secondary procedure.A computed tomography scan was completed on (b)(6) 2023 and an endoleak was noted and thought to be a type 3b endoleak.An ultrasound bubble test was also performed after the reintervention procedure in 2020.On (b)(6) 2023 a reintervention procedure was completed with the intention to reline the distal end of the zenith flex aaa endovascular graft bifurcated main body as it was thought that a fabric tear was present.However, during the procedure it was discovered that the zenith flex aaa endovascular graft bifurcated main body had completely separated from the bridging limb, zenith flex with spiral-z technology aaa endovascular graft iliac leg.A new limb was placed to seal between the zenith flex aaa endovascular graft bifurcated main body and the zenith branch endovascular graft iliac bifurcation to resolve the endoleak.During expert review of imaging provided for the investigation of events with patient identifier: (b)(6), a type 1b endoleak was identified on the left zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt), which is the focus of this investigation.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 dhr for the reported complaint device revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev3 ¿zenith spiral-z aaa iliac leg 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 enlarging aneurysms, 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 ¿ zenith spiral-z 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.4.3 pre-procedure measurement techniques and imaging lengths ¿ 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 aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.¿ after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity, and progressive disease.If renal complications or other factors precluded the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.4.4 device selection ¿ strict adherence to the zenith spiral-z aaa iliac leg 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 spiral-z aaa iliac leg and assure accurate apposition to the vessel wall.¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ aneurysm enlargement ¿ aneurysm rupture and death ¿ aortic damage, including perforation, dissection, bleeding, rupture and death ¿ endoleak ¿ endoprosthesis: improper component placement, incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion 8 patient counseling information ¿ 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.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.12 imaging guidelines and postoperative follow-up 12.1 general ¿ all patients should be advised that endovascular treatment requires lifelong, 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.¿ imaging in the form of computed tomography and angiography was provided and an imaging review was completed by a physician.The image reviewer¿s impression: ¿1.An infrarenal aorto-iliac aneurysm was previously treated using a tffb-36-95 main body graft, a contralateral zsle-16-56 bridging leg with a zbis-10-45-41 branch graft on the right, and an ipsilateral zsle-20-56 leg on the left.2.Per the report, a type 1a endoleak due to disease progression developed around the proximal tffb graft at 6 years postop (2020).This is not demonstrated on the imaging provided and is based solely on the report.Proximal extension was performed using a fenestrated-thoracoabdominal graft with adequate proximal seal and no type 1a endoleak seen at 9 years on the imaging provided.3.At 9 years, there is complete separation and loss of overlap between the contralateral limb of the tffb graft and the proximal right zsle (16 x 56 mm) leg, resulting in a type 3a endoleak.4.Given the postop timeframe and previous report of disease progression, this could be due to aortic elongation.5.It is unclear how much sac diameter growth there has been from the initial implant, but increased diameter alone could have affected the graft conformation/position by gradually conforming to the outer anterior curve of the enlarging aaa sac, resulting in significant outward bending of the graft and angulation at the limbs and thus elongating the graft-centerline distance from the renals to the iliacs.The anatomic centerline distance from the proximal tffb graft to the distal zbis graft through the aaa sac is 196 mm on the ct provided, while the true graft centerline distance with its current positioning is 238 mm.If this position was a shift from the initial placement, it could have caused gradual distraction of the components with loss of overlap, as on the right side.This might have also caused retraction of the left zsle leg into the proximal-mid left cia with decreased coverage and loss of graft wall apposition here.Early postop imaging would be needed to compare the component positions and appearance to confirm this, however.6.Incidentally, there is a limited type 1b endoleak around the distal edge of the left zsle leg due to lack of graft wall apposition in the proximal to mid left cia.The endoleak does not extend proximally, but there is a high risk for loss of distal seal here.This could be due to proximal migration/retraction of the left zsle leg with reduced coverage in the left cia due to aortic elongation or shift in tffb graft/limb positioning in the aaa sac, as noted above.Again, early postop imaging would be needed to compare with the initial left zsle position to confirm this, however.¿ based on the information provided, expert review of medical imaging provided by the facility, and the results of our investigation, a definitive cause for the failure mode could not be determined.It is possible patient condition/anatomy was a contributing factor.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.Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of (b)(6) 2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on (b)(6) 2023.Per (b)(4), questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: ¿¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational.¿ an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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: 17876289
• Report Number: 1820334-2023-01339
• Device Sequence Number: 4450226
• Product Code: MIH
• UDI-Device Identifier: 10827002552415
• UDI-Public: (01)10827002552415(17)170201(10)4792180
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 02/01/2017
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-56-ZT
• Device Lot Number: 4792180
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK RPN:TFFB-36-95-ZT, LOT 4053084.; COOK RPN:ZBIS-10-45-41 LOT A937127.; COOK RPN:ZSLE-16-56-ZT LOT 4715582.
• Patient Sex: Male