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

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: professor.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a (b)(6) year-old male patient experienced a lack of patency following implantation of a zenith flex with spiral-z technology aaa endovascular graft iliac leg.Prior to the initial implantation, a pre-procedure ct scan taken on (b)(6) 2017 (231 days pre-procedure) showed a stable, juxtarenal, abdominal aortic aneurysm with a maximum diameter of 66mm.The patient's celiac, superior-mesenteric, and renal arteries were all patent.No renal infarcts were observed and there was evidence of mild iliac angulation.On (b)(6) 2017, the patient underwent an endovascular procedure in which six cook devices, including the complaint device, and six competitor grafts were implanted.There was no reported difficulty during deployment of the devices.Post-procedure imaging showed no evidence of device integrity issues or any other abnormalities.At the one-month clinical assessment on (b)(6) 2018 (106 days post-procedure), ultrasound imaging revealed a distal type 1 endoleak (not in relation to the complaint device).The celiac, superior-mesenteric, and renal arteries remained patent.At the six-month clinical assessment on (b)(6) 2018 (317 days post-procedure), ct imaging revealed a type iii endoleak on the right iliac branched graft.The celiac, superior-mesenteric, and renal arteries remained patent and the maximum aneurysm diameter measured at 96mm.As a result, a successful secondary intervention was performed on (b)(6) 2018 in which a competitor device was implanted.At the one-year clinical assessment on (b)(6) 2019 (477 days post-initial procedure), ct imaging revealed a type ii endoleak.The celiac, superior-mesenteric, and renal arteries remained patent and the maximum aneurysm diameter measured at 86mm.No secondary intervention took place as a result of the endoleak.At the two-year clinical assessment on (b)(6) 2019 (766 days post-initial procedure), both ct and ultrasound imaging were performed, revealing patent celiac, superior-mesenteric, and renal arteries.There was no evidence of an endoleak, device migration, separation of components, or device integrity issues.The ultrasound imaging showed a maximum aneurysm diameter of 94mm, while the ct imaging showed a maximum aneurysm diameter of 103mm.On (b)(6) 2020 (981 days post-initial procedure), the patient experienced a vascular event of thrombosis of the proximal internal iliac artery.The event was treated medically and has been marked as ongoing.On (b)(6) 2020 (983 days post-initial procedure), the patient presented with claudication symptoms and had a vascular event of a common right femoral artery aneurysm measuring at 30mm, which was treated successfully by "another intervention not related to evar a right femo-femoral bypass".As a result, the patient was hospitalized from (b)(6) 2020 to (b)(6) 2020.This event was not considered to be in relation to the initial procedure.At the three-year clinical assessment on (b)(6) 2020 (990 days post-initial procedure), ct imaging revealed no evidence of an endoleak, device migration, separation of components, or device integrity issues.The celiac, superior-mesenteric, and renal arteries were patent; however, there was a lack of patency noted for the right iliac leg graft, which is the subject of this report.No other adverse effects or secondary interventions related to the loss of patency in the right iliac leg graft have been reported.The patient currently remains in the study.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation.(b)(6) informed cook on 21dec2020 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-56-zt) from lot 7830135.A lack of patency in a leg graft was reported during a follow-up on 19jan2021.No adverse effects were reported to the patient as a result of this incident.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), 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 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 (7830135) and the related subassembly lot revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.It should be noted that zsle devices are distributed via one-device lots.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, cook has concluded that there is no evidence that nonconforming product exists either in house or in the field and that the complaint lot was manufactured to current specifications.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: ¿ 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: ¿ adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 14 french to 16 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.¿ 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.Dilation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary (e.G., adjunctive ballooning or stenting).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.¿ follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patients with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.¿ patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.4.5 implant procedure: ¿ systemic anticoagulation should be used during the implant procedure based on hospital- and physician-preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.¿ use caution during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization, or may rupture the aneurysm.¿ excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.5 adverse events.5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: ¿ arterial or venous thrombosis and/or pseudoaneurysm.¿ claudication (e.G., buttock, lower limb).¿ embolization (micro and macro) with transient or permanent ischemia or infarction.¿ endoprosthesis: occlusion.¿ graft or native vessel occlusion.¿ renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).11 directions for use.11.1 zenith spiral-z aaa iliac leg system.11.1.4 contralateral iliac leg placement and deployment.3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until at least one stent of the iliac leg graft overlaps within the main body 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.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency, a minimum overlap of one stent, and a maximum overlap of 30 mm within the main body endovascular graft.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.3.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root for this event was unable to be established.However, it should be noted that loss of patency is a known inherent risk of using this device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11109281
• MDR Text Key: 258582135
• Report Number: 1820334-2021-00004
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552316
• UDI-Public: (01)10827002552316(17)200425(10)7830135
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-13-56-ZT
• Device Lot Number: 7830135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 03/27/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK PRELOADED FENESTRATED PROX; COOK ZBIS-12-45-41; COOK ZFEN-D-12-45-94; COOK ZISL-13-59; COOK ZISL-16-59; NON-COOK BGP27072, CELIAC STENT; NON-COOK BGP27081, SMA STENT; NON-COOK BGP37102, RIGHT INTERVAL ILIAC ARTERY; NON-COOK V12D5L22, RENAL STENT, RIGHT; NON-COOK V12D6L22 85353, RENAL STENT, LEFT; NON-COOK ZVM12060, EXTERNAL ILIAC ARTERY STENT; NONCOOK BGP37101, LEFT INTERNAL ILIAC ARTERY STENT
• Patient Age: 68 YR
• Patient Weight: 104