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	G55238
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041); No Code Available (3191)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: zfen-p-2-26-124-r, lot ac1057288, zfen-d-16-62-91-c, lot ac1057290, 2 ea icast stents, both 6mm in diameter and 22mm in length.The physician brought the patient back to or.He tried to get back into the renal artery stent to reopen it but was unable to select it with a wire.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 dilator tip of a zenith flex with spiral-z technology aaa endovascular graft iliac leg was too long for the procedure and crushed the left renal artery stent that was implanted.The zenith flex with spiral-z technology aaa endovascular graft iliac leg was used in a fenestrated evar case along with two zenith fenestrated devices and renal stents.The patient had minimal calcification around the sma, renal arteries, and external iliac arteries.The common iliac arteries were more calcified and some angulation in the abdominal aorta was observed.During advancement, the dilator tip of the zenith iliac leg crushed the left renal artery stent and prevented blood flow to the kidney.Ultimately, all devices were able to be placed in the intended spots.At the end of the procedure, the final angiogram showed perfusion to the sma and both renal arteries.No issue with the renal stent was noticed at that time.To treat the patient for "kidney shutdown", the physician brought the patient back to the operating room in an attempt to "get back into the renal artery stent to reopen it but was unable to select it with a wire".
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.An 83 year old male patient underwent a fenestrated endovascular abdominal aortic aneurysm procedure during which time 2 zenith fenestrated devices, renal stents, and a zsle16-74-zt were implanted.When the physician used the iliac leg device, it was reported that the dilator tip of the iliac limb crushed the left renal artery stent and did not allow blood to flow to the kidney.The physician provided feedback that the dilator tip is too long for fenestrated cases.At the end of the procedure, the grafts were placed in their intended spots and the final angiogram showed perfusion to the superior mesenteric artery (sma) and both renal arteries.No issue with the renal stent was noticed at that time.However, it was believed that "kidney shutdown" occurred so the physician brought the patient back for reintervention to reopen the renal stent.Gaining access to the artery via wire was unsuccessful.The patient had minimal calcification around sma and renal arteries, and external iliac arteries.The common iliac arteries were more calcified and some angulation in the abdominal aorta was observed.A review of the documentation including the complaint history, device history record, drawing, instructions for use (ifu) and quality control w of the device was conducted during the investigation.The complaint device was not returned for evaluation; however, a photograph of a radiographic image from the case was provided.The image showed the body of the stent graft placed in the aorta with the medial portion of the left renal stent graft distorted.The stent is compressed and angled superiorly.This corresponds to the reported complaint and would be expected to have occurred during advancement of the zsle delivery system based on the inferior vascular approach, with respect to the renal arteries.The image did not include context related to the length of the dilator tip.Cook has concluded that the device was manufactured to specification.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 device history record found no nonconformances or additional complaints associated with the reported device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: warnings and precautions: 4.2 patient selection, treatment and follow-up ¿ the zenith spiral-z aaa iliac leg with the z-trak introduction system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.4.5 implant procedure: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.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.As the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monito graft position and perform angiography to check position as necessary.Avoid damaging the graft or disturbing graft positioning after placement in the event reinstrumentation (secondary intervention) of the graft is necessary.Adverse events: 5.2 potential adverse events endoprosthesis¿occlusion¿ genitourinary complications and subsequent attendant problems (e.G., ischemia, erosion, fistula, incontinence, hematuria, infection) graft or native vessel occlusion renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).Directions for use: note: if difficulty is encountered advancing the iliac leg delivery system, exhance to a more supportive wire guide.In tortuous vessels the anatomy may alter significantly with the introduction of the rigid wires and sheath systems.Final angiogram : 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent.Imaging guidelines and postoperative follow-up: 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.Based on the information provided, inspection of the provided image, and the results of the investigation, a definitive cause for the difficult advancement of the sheath was traced to unintended user error pertaining to the technique used to support the fenestrated case.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.

• 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: 9996696
• Report Number: 1820334-2020-00868
• Device Sequence Number: 17102813
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)230127(10)10286156
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: G55238
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 10286156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR