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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Paresthesia (4421)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

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 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 or that a death or serious injury occurred; nor is it admission 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 Description

It was reported that a study patient required a surgical femoral endarterectomy for "mobilization of femoral plaques" after the placement of cook devices on (b)(6) 2023.The patient was 62 years old at the time of the custom-made device procedure.He had been diagnosed with hypertension and had history of open abdominal surgery.The patients juxtarenal aortic neck measured (<10 mm).His abdominal aortic aneurysm (aaa) had a history of growth greater than or equal to 1.0 cm/year.No repair procedures had been completed after the prior endovascular aortic repair (evar).Pre-procedure imaging using contrast was completed on (b)(6) 2023.The innominate artery, right common carotid artery, right subclavian artery, left common carotid artery, left subclavian artery, celiac artery were all patent and no stenosis greater than 50% was identified.The superior mesenteric artery was patent and no stenosis greater than 50% was identified.The right renal artery was patent and no stenosis greater than 50% was identified.The left renal artery was patent and no stenosis greater than 50% was identified.The right accessory renal artery was patent and no stenosis greater than 50% was identified.The left accessory renal artery was patent and no stenosis greater than 50% was identified.The right common iliac artery was patent.The left common iliac artery was patent.The left and right internal iliac artery arteries were both patent.The method of length measurement used was centerline.The maximum diameter of the diseased aorta on centerline was 50 mm.The intended proximal landing zone was zone 5: mid descending aorta to celiac.The shape was irregular.The intended distal landing zone was left and right zone 11: external iliac arteries.On (b)(6) 2023 the patient underwent endovascular aortic repair (evar).The following cook devices were implanted during the procedure: pre-loaded-fenestrated-prox a aaa-bifurcated-graft.Zenith spiral-z aaa iliac leg graft (rpn:zsle-16-39-zt).Zenith spiral-z aaa iliac leg graft (rpn:zsle-16-59-zt).There were no technical difficulties in the delivery and deployment of the cook grafts.The delivery and deployment were considered successful.Competitor's grafts were placed in the superior mesenteric artery (sma), right renal artery, right renal accessory artery, left renal artery, and left renal accessory artery.The arteries were revascularized with the fenestrated-branched device.The covered stents were not relined with a bare metal stent and were not extended distally with a bare metal stent.The side branch catheterization and placement of the bridging stent were considered successful.The stent patency was maintained with normal end artery perfusion.Procedural imaging (cone beam computed tomography (ct) ) with contrast was completed on (b)(6) 2023.All of the stent grafts and intended side branch stents were patent as the conclusion of the procedure.All target vessels were patent.This was confirmed by an angiogram.No endoleaks were present at the conclusion of the procedure.This was confirmed by angiogram and cone beam (ct).There was no evidence of stent graft integrity issues.This was confirmed with cone beam ct with contrast.All target side branch stents were intact.More than or equal to three stents overlapped between the distal device and the arch device proximal to it.The overlap between the distal device and the arch graft was not bridged with an additional tevar device.Stents overlapped between distal device and the additional distal device were 1-1.9.The overlap between the distal device and additional distal device was not bridged with an additional tevar device.Symptoms of lower limb paresthesia began on (b)(6) 2023 and then continued to (b)(6) 2023.On (b)(6) 2023 vascular stenosis greater than 50% was identified in the native vessel in the non-stented area and a femoral endarterectomy was completed.The site indicated that the study procedure cause or contributed to this event "mobilisation of femoral plaques" and contributed to in patient hospitalization or prolongation of patient hospitalization.The femoral endarterectomy was considered successful.The patient stayed in the intensive care unit for three nights.The time from intubation to extubation was under 12 hours.His highest creatinine during the index hospitalization was 1 mg/dl.His egfr on discharge was 81 ml/min/1.73 m2).The lowest hematocrit during the index hospitalization was 20%.His hematocrit on discharge was 27%.The highest white blood count during the index hospitalization was 17 cells/mm3.The patient required 1 unit of packed red blood cells during the operation and over the entire hospitalization.The lowest platelet count during the hospitalization was 28 count x1000/ml).The patient was hospitalized from (b)(6) 2023.The patient was discharged home on (b)(6) 2023.He was prescribed acetylsalicylic acid (asa), a statin, and apixaban.Beginning on (b)(6) 2023 symptoms of an access site infection began.A procedure to perform groin debridement and local dehiscence was completed on (b)(6) 2023.The access site infection was attributed to the patient's anatomy, pre-existing condition, and a comorbidity diagnosed after the study procedure, specifically the patient's obesity.The debridement procedure was considered successful.The focus of this report is the "mobilisation of femoral plaques" that required a femoral endarterectomy after the index evar procedure where a cook zenith flex with spiral-z technology aaa endovascular graft iliac (rpn: zsle-16-56-zt) was placed.An additional report will be sent for the patient identifier (b)(6).

Manufacturer Narrative

This event is no longer considered a reportable event.Based on the available information, imaging review, and the results of the investigation cook has not confirmed the relationship of the reported stenosis to the zsle graft.The image reviewer noted, ¿about 1 month postop, the patient developed lower extremity paresthesia and was found to have >50% of the native ¿non-stented¿ vessel requiring femoral endarterectomy.This is most likely due to the index procedure but unrelated to the zsle iliac leg grafts.¿ in the index procedure, the zsle devices are the final devices placed and are most often delivered through the sheaths of previously deployed devices.Therefore, mobilization of femoral plaques is unlikely related to the zsle device.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 or that a death or serious injury occurred; nor is it admission 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 Description

This event no longer meets the qualifications for a reportable event.

• 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
• 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: 18627211
• MDR Text Key: 334370169
• Report Number: 1820334-2024-00158
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552378
• UDI-Public: (01)10827002552378(17)260606(10)15475748
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-56-ZT
• Device Lot Number: 15475748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BEGRAFT PERIPHERAL STENT, 5 MM X 22 MM; BEGRAFT PERIPHERAL STENT, 8 MM X 27 MM; COOK AAA-BIFURCATED-GRAFT, LOT AC1133427; COOK CODA-2-9.0-35-120-32, LOT 15366698; COOK HNBR5.0-35-65-P-NS-RIM, LOT 15203659; COOK HNBR5.0-38-100-P-NS-VS2, LOT 13708120; COOK HNBR5.0-38-65-P-NS-KMP, LOT 15459208; COOK KCFW-12.0-35-45-RB-HFANL1-HC, LOT 15445653; COOK KCFW-6.0-18/38-90-RB-ANL1-HC, LOT 15236628; COOK KCFW-6.0-35-55-RB-HFANL1-HC, LOT 15424650; COOK KCFW-6.0-35-55-RB-HFANL1-HC, LOT 15445658; COOK PRE-LOADED-FENESTRATED-PROX, LOT AC1133456; COOK THSCF-35-260-1.5-ROSEN, LOT 14994744; COOK TSCMG-35-260-7-LES, LOT E4415265; COOK ZSLE-16-39-ZT, LOT 15076690
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG