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); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	11/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: zalb-26-84, lot number 3947278 via right side, zsle-13-107-zt lot 3283615 via right side.(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 that the patient presented at the hospital with a type iii endoleak the contralateral zenith flex with spiral-z technology aaa endovascular graft iliac leg was found to be separated from the zalb mainbody.A procedure set for (b)(6) 2019 is planned to cannulate the contralateral gate and deploy a new 13mm limb to bridge the dislocated limb to the graft in order to seal the endoleak.It was later reported on (b)(6) 2019 that the patient had died, as the aneurysm had ruptured.
Additional Manufacturer Narrative
Additional information: h6- device code.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control, as well as a visual inspection of imaging provided of the device was conducted during the investigation.The visual inspection of the complaint device could not be completed as the device was not returned for evaluation.However, ct imaging dated 6 years post-operation was provided and sent for expert review.Image review noted complete separation of the complaint device, the proximal left graft, from the main body ipsilateral limb.This resulted in a large type 3a endoleak due to the large gap between the two components.Additionally, the right graft had inadequate overlap within the contralateral limb and the main body had a proximal seal length of 2 mm below the lowest renal artery with no sign of a type 1a endoleak.The provided imaging gave no indication that any of the implanted devices were manufactured out of specifications.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the the affected product is safe and effective for its intended use.A review of the device history record found no nonconformances or additional complaints associated with the complaint device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Cook also completed a review of the product labeling for the device.The instructions for use state the following instructions related to the reported failure mode: 2 indications for use: "the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, or zenith branch iliac endovascular graft, during either primary or secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems." 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.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.4.4 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 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.¿ inadequate overlap of the zenith spiral-z aaa iliac leg 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: aneurysm enlargement, aneurysm 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." 11 directions for use: "11.1.4 contralateral iliac leg placement and deployment: 3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until the iliac leg graft overlaps at least one stent and not past the radiopaque marker band positioned 30 mm from the proximal end of the iliac leg graft inside the contralateral limb of the main body.If there is any tendency for the main body graft to move during this maneuver, hold it in position by stabilizing the grey positioner on the ipsilateral side.Note: a radiopaque marker band is positioned 30 mm from the proximal end of the iliac leg graft to identify the maximum amount of overlap.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure both internal iliac patency and a maximum overlap of 30 mm within the main body endovascular graft.5.To deploy, hold the iliac leg graft in position with the gripper on the grey positioner while withdrawing the sheath.Ensure overlap is maintained.6.Stop withdrawing the sheath as soon as the distal end of the iliac leg graft is released.11.1.5 ipsilateral iliac leg placement and deployment: 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.- note: if an overlap of greater than 55 mm is required, it may be necessary to consider use of a leg extension in the bifurcation area of that opposite side.3.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.4.To deploy, stabilize the iliac leg graft with the gripper on the grey positioner while withdrawing the iliac leg sheath.If necessary, withdraw the main body sheath.11.1.6 molding balloon insertion: 6.Withdraw the molding balloon to the ipsilateral limb overlap and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation side and expand.8.Deflate and remove the molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand." 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 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.[¿] 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.12.2 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type iii endoleak, aneurysm enlargement [greater than or equal to] 5 mm of maximum diameter (regardless of endoleak status), migration, inadequate seal length".Potential contributing factors identified for component separation include disease progression and improper device placement during the implant procedure.Based on the information and imaging provided, the component separation between the left zsle-13-74 and mainbody ipsilateral limb was most likely caused by aaa elongation and sac growth from disease progression.Improper placement (inadequate overlap) of the main body and bilateral zsle grafts during the implantation procedure can not be ruled out as a possible contributing factor for this event.A definitive conclusion can not be definitively determined without the review of pre-operative or post-operative follow up imaging prior to the reported event.Component separation between the main body and leg graft is listed as a potential adverse effect in the product ifu and is a known inherent risk for this device.The appropriate personnel have been notified.Per the quality engineering 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.
Event or Problem Description
No additional patient/event details have 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
• MDR Report Key: 9347394
• Report Number: 1820334-2019-02924
• Device Sequence Number: 2852802
• Product Code: MIH
• UDI-Device Identifier: 10827002552323
• UDI-Public: (01)10827002552323(17)151101(10)3816386
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 11/01/2015
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-13-74-ZT
• Device Lot Number: 3816386
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Death