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 Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).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 slight type 1b endoleak developed on a zenith flex with spiral-z technology aaa endovascular graft iliac leg implanted on the right side during an evar procedure.The patient had several "cardiac cath procedures with groin access" prior to their aaa repair.During the procedure, the physician was unable to track the sheath into the patient.After pulling the delivery system out a bit, it was able to be re-advanced smoothly.The device was then taken off of the wire and dilators were used to dilate the patient's vessels without issues.The physician then attempted to insert the main body device, but found that it was not tracking into the patient's groin.Another device was able to be "advanced perfectly" and was thus used to complete the procedure without issues.Heparin was administered intraoperatively.Posterior calcium was used at the access site.The patient's vessels were reported to have been greater than 8mm with the posterior calcium.The case was described to be "straight-forward and per ifu" and the graft was not altered in any way prior to use.A slight type 1b endoleak was noticed during the procedure on the right side.Re-ballooning was attempted, but the endoleak persisted.The rest of the procedure was completed "fine" and the patient was discharged from the hospital.The patient "was doing fine" at their one-month post-surgery follow-up where a ct scan was completed.Another event associated with this patient is also reported under patient identifier: (b)(6).

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A1 - patient identifier: (b)(6).Investigation - evaluation.(b)(6) hospital informed cook on 20jan2021 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg ((b)(6)) from lot 8572470.A 1b endoleak was reportedly noted on the right leg graft following an evar procedure on (b)(6) 2021.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control 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 (8572470) and the related subassembly lot revealed no recorded nonconformances relevant to the reported failure mode.It should be noted that zsle- devices are distributed via one-device lots, giving no indication of nonconforming product in house.A database search did not identify any other events associated with the reported device lot.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 suggesting nonconforming product exists either 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-trak 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.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.4.3 pre-procedure measurement techniques and imaging: diameters: utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.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 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: ¿ 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 adverse events: 5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: ¿ endoleak.11 directions for use.11.1 zenith spiral-z aaa iliac leg system.11.1.7 molding balloon insertion.5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove 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.Final angiogram: 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12imaging guidelines and post operative 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.12.2 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: ¿ aneurysms with type i endoleak¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event was unable to be established.However, it should be noted that endoleaks are a known inherent risk of using this device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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
• 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: 11287901
• MDR Text Key: 266295870
• Report Number: 1820334-2021-00267
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552477
• UDI-Public: (01)10827002552477(17)210216(10)8572470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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: 02/16/2021
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-90-ZT
• Device Lot Number: 8572470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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: 16 FR. DILATOR.; 18 FR. DILATOR.; 32 CODA BALLOON.; COOK PIGTAIL CATHETER.; LUNDERQUIST WIRE QTY. 2.; PRO-GLIDE CLOSURE DEVICES QTY. 2.; TFFB-28-82-ZT.; TFFB-28-96-ZT.; ZSLE-16-90-ZT.
• Patient Age: 71 YR
• Patient Sex: Male