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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a type 1b endoleak occurred on a zenith flex with spiral-z technology aaa endovascular graft iliac leg following an endovascular aortic repair (evar) procedure.Some time in (b)(6) 2015, the patient received four self-expanding stents, a custom-made aaa bifurcated graft, and the zenith iliac leg graft.About 8 years post index procedure, a type 1b endoleak was discovered in both common iliac arteries.The devices remain inside the patient's body.The patient will be treated with additional endovascular grafts to treat the progressive disease in the common iliac arteries, however a procedure date has not been confirmed.Additional information regarding the event and patient outcome has been requested but is currently unavailable.This report captures the type 1b endoleak on the zenith iliac leg graft.
Additional Manufacturer Narrative
Initial reporter health professional: vascular surgeon.The custom made bifurcated graft that experienced a type 1b endoleak is not cleared for sale in the u.S.This device is not same or similar to a device sold in the u.S.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: b1, b2, h1, h6 - health eff impact code.Investigation ¿ evaluation.(b)(6) hospital informed cook of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-16-74-zt) lot 4829219.The male patient, date of birth (b)(6) 1936, had an initial evar (endovascular aneurysm repair) procedure completed in (b)(6) 2015.A zfen-d (lot unknown) was also placed in the initial procedure.The site reported type 1b endoleaks in both common iliacs.This investigation will capture the type 1b endoleak involving the zsle-16-74-zt.The patient¿s only reported pre-existing condition was supracoeliac aortic aneurysm.The site has stated the endoleak happened as a result of progressive disease.The endoleak will be treated with placement of additional endovascular grafts.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, expert review of the event details, patient anatomy sketch, and images received from the site was conducted.The reviewer noted that it is a simple case of disease progression and that the type 1b endoleaks are due to the progressive dilatation of the iliac arteries at the distal end of the previous (8-year-old) grafts.Additionally, a document based investigation evaluation was performed.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 device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots found no nonconformances.A database search was completed for lot 4829219 and found no other lot related complaints.Because adequate inspection activities have been established and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists 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-track 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.¿ pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.4.3 pre-procedure measurement techniques and imaging: ¿ 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 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.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: - 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.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.Evidence provided by the complaint facility, device failure analysis, device history record, complaint history, manufacturing documents, and verification testing, 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.Based on the information provided by the facility, expert review of the provided images, and the results of the investigation, cook has determined this failure mode occurred as a result of patient condition/disease progression.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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: 14087979
• Report Number: 1820334-2022-00559
• Device Sequence Number: 5288870
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)170301(10)4829219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/08/2022

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: 03/01/2017
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 4829219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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 CUSTOM MADE BIFURCATED GRAFT.; COOK ZFV6-80-7-6.0, LOT CF742305.; COOK ZFV6-80-7-6.0, LOT CF742305.; COOK ZFV6-80-8-6.0, LOT C817726.; COOK ZSLE-16-74-ZT, LOT 4829219.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male