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 Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer (person): additional information - postal code: (b)(6).Occupation: vascular surgeon.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
A 74 year old female patient required a relining procedure for a type 3b endoleak in an existing zenith flex with spiral-z technology aaa endovascular graft iliac leg.The patient had a cook custom fenestrated graft, cook zenith tx2 taa endovascular graft proximal component, and a cook zenith flex with spiral-z technology aaa endovascular graft iliac leg placed at epworth centre, victoria, australia on an unknown date.It was reported that a type 3b endoleak described as a "hole" was present in cook grafts in situ.An imaging report was generated by the customer and provided to cook on (b)(6) 2023.Chest x-ray: the patient had history of post ligation coeliac artery for endoleak with right renal artery transposition for sma graft revision.Chest x-ray findings: a thoracic aortic endograph is in situ.When compared with yesterday's radiograph the central venous catheter has been removed and there is no evidence of a pneumothorax.Widening of the mediastinum likely relates to descending thoracic aortic aneurysm.There has been no alteration in the mediastinal contour and there is a persistent small left pleural effusion.Ct thoracic and abdominal angiogram: technique: pre and post intravenous contrast enhanced ct of the chest, abdomen and pelvis has been performed in arterial and portal venous phases with multiplanar reformat.Findings: no prior imaging of the chest, abdomen or pelvis available for comparison at the time of reporting.A aortic stent is in situ extending from the thoracic aorta to the aortic bifurcation.The proximal aspect of the thoracic graft partially covers the left subclavian artery.Within limitations of non dedicated examination, the subclavian and vertebral arteries appear to opacify distal to the ostium.There is a large thoracic aneurysm with a maximum transverse dimension of 71mm.There are internal high attenuating contents within the native aneurysmal sac with evidence of an endoleak just proximal to the diaphragmatic hiatus.The native aneurysm extends inferiorly to involve the abdominal aorta with a maximum diameter of 60mm with ectasia extending down to the left common iliac artery.Ligation of the coeliac trunk.The sma ostium has been occluded with an amplatzer device as has the right renal artery.The right external iliac artery has been anastomosed, supplying the supplying the sma.The transposed right renal artery appears to demonstrate a high grade stenosis at its ostium.This kidney demonstrates a delayed nephrogram and is relatively small in volume in relation to the left kidney.I note the abnormal differential function demonstrated on renal study performed 05/10/2022.The hepatic and splenic arteries are patent.Small bilateral pleural effusions.Small volume dependent fluid in the pelvis.No suspicious osseous lesion identified.Conclusion: delayed nephrogram right renal artery with apparent stenosis at the right renal artery anastomosis.Patent mesenteric arteries with iliac anastomosis.Distal thoracic endoleak with distal thoracic native aneurysmal sac measuring 71mm.It was reported that the existing grafts required re-lining.The patient had successful coverage of the suspected hole/endoleak.The patient's pre-existing conditions and co-morbidities are unknown.No implantation/previous surgery notes are available as the patient was previously treated at another facility.No adverse effect on the patient was reported due to this occurrence.This report captures the type 3 b endoleak in the zenith flex with spiral-z technology aaa endovascular graft iliac leg.
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
Correction: h6 - annex a.Investigation / evaluation: a vascular surgeon from (b)(6) hospital informed cook on 16mar2023 of an event with a 74-year-old female patient with a type 3 endoleak in an implanted cook grafts, but no further information was available.Upon image review, it was discovered that a zisl leg graft had been placed to extend the seal of a zsle leg graft.The image reviewer suggested that this may have been placed to treat a type 1b endoleak on the zsle graft.Therefore, cook opened this complaint to investigate the possible type 1b endoleak on the zsle-16-90-zt leg graft from lot: 4940540.The complaint device was zenith flex with spiral-z technology aaa endovascular leg (rpn: zsle-16-90-zt; lot: 4940540).The initial date of implant was in 2014 and the following devices were implanted: zsle-16-90-zt (product lot: 4940540), zteg-2p-38-152-pf (product lot: e2428535).It is unknown if the patient had any pre-existing conditions or comorbidities in addition to the aaa.The physician performed an additional procedure relining the existing grafts.Reviews of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications 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.An extent ii taaa was previously repaired using 2 proximal zteg grafts, a fenestrated cmd graft, a universal distal unibody with an ipsilateral extension leg graft on the right, and a zsle-16-90 leg graft on the left.No endoleak involving the proximal zteg (2p-38-152) or zsle-16-90 leg is identified on this imaging.It is unclear if the extension zisl leg graft on the left was implanted later to treat an endoleak involving the zsle leg.This cannot be determined from the information in the complaint report or from the imaging provided.There is a focal limited endoleak in the distal ta where the distal zteg graft overlaps with the proximal cmd graft.The endoleak appears to communicate with the outer zteg graft where a barb from the fixation stent of the inner cmd is located, consistent with a type 3b endoleak from a fabric puncture.This distal zteg graft is not identified in the complaint report.Based on measurements from the current study, this is most likely a 200-mm length graft (10 stent segments) with an unknown nominal diameter.The measured diameter is 26.5 mm proximally, 28 x 23 at the mid segment, and 22 mm distally.Incidentally, there is a focal limited type 2 endoleak in the distal abdominal aortic from patent lumbar branches.This is away from any graft.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: 4940540 and the related subassembly lots revealed no related non-conformances.No other complaints have been reported for this lot.Evidence provided by the customer, complaint history, device history record, device failure analysis, and manufacturing documents suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.The device was packaged with ifu t_zaaasz_rev3.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.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 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: successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedure measurement techniques, and imaging.4.3 pre-procedure measurement techniques and imaging: clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (cta) with 3-d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with the zenith spiral-z aaa iliac leg.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.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.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative 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 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 preclude 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 (table 10.5.1).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 spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.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.Avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.5 adverse events: 5.2 potential adverse events: aneurysm enlargement aneurysm rupture and death claudication (e.G., buttock, lower limb) 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.Surgical conversion to open repair.7 patient selection and treatment.7.1 individualization of treatment.Additional considerations for patient selection include, but are not limited to: patient¿s age and life expectancy co-morbidities (e.G., cardiac, pulmonary, or renal insufficiency prior to surgery, morbid obesity).Patient¿s suitability for open surgical repair patient¿s anatomical suitability for endovascular repair patient¿s ability to tolerate general, regional, or local anesthesia.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.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.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a life-long commitment to the patient¿s health and well-being.Physicians must advise all patients that it is important to seek prompt medical attention if they experience signs of limb occlusion, aneurysm enlargement or rupture.Signs of graft limb occlusion include pain in the hip(s) or leg(s) during walking or at rest or discoloration or coolness of the leg.Aneurysm rupture may be asymptomatic, but usually presents as: pain; numbness; weakness in the legs; any back, chest, abdominal or groin pain; dizziness; fainting rapid heartbeat or sudden weakness.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 (see section 5.1, observed adverse events and section 5.2, potential adverse events).The physician should complete the patient i.D.Card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures.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.Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient.The minimum requirement for patient follow-up (described in the instructions for use for the zenith aaa device that was used should be maintained even in the absence of clinical symptoms (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.The combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity, and progressive disease.In this circumstance, a non-contrast ct should be performed to use in conjunction with the ultrasound.Ultrasound may be a less reliable and sensitive diagnostic method compared to ct.Based on the information provided, expert review of medical imaging provided by the facility, and the results of our investigation, cook could not establish a definitive cause for the reported failure.The image reviewer does not confirm an endoleak on the zsle device but does confirm the endoleak on a different graft.In addition, the reviewer says, ¿it is unclear if the extension zisl leg graft on the left was implanted later to treat an endoleak involving the zsle leg.¿ 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 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: 16704417
• Report Number: 1820334-2023-00387
• Device Sequence Number: 3584969
• Product Code: MIH
• UDI-Device Identifier: 10827002552392
• UDI-Public: (01)10827002552392(17)170501(10)4940540
• 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): 05/30/2023

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: 05/01/2017
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-90-ZT
• Device Lot Number: 4940540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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 G32595, LOT AC936451.; COOK G38035, LOT AC936428.; COOK G38046, LOT AC936452.; COOK, ZTEG-2P-38-152-PF, LOT E2428535.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female