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 Use of Device Problem (1670)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Phone: (b)(6).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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

A patient underwent a fenestrated endovascular aortic repair on (b)(6) 2023.A cook custom made graft was first placed in the patient.A zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt) delivery system was introduced into the custom-made graft from the left groin.During the introduction it was reported that the tip of the zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt) delivery system damaged the bridging stent of the left renal fenestration of the custom-made graft.After the devices were placed, the physician performed a cone beam computed tomography (ct) scan and discovered the stent in the left renal artery was damaged.A reintervention to address the damaged left renal stent included re- catheterization and percutaneous transluminal angioplasty (pta) using a balloon.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: (b)(6) informed cook on (b)(6) 2023 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt, lot 14695385).On (b)(6) 2023, the female patient of unknown age had a fenestrated endovascular aortic repair (fevar) in the aorta.After placement of the custom made fenestrated proximal device and the aaa bifurcated graft, the zsle-20-74-zt was introduced.According to the site, while introducing the device, the long tip of the introducer system caused damage to the protruding bridging stent of the left renal fenestration.Re-catheterization and percutaneous transluminal angioplasty (pta) were performed.Reviews of the documentation, including the complaint history, device history record, drawing, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, two still images were provided by the site for expert review.The reviewer noted that the introducer tip was approximately at the level of the left small fenestration, with aortic angulating inclining the introducer towards the affected site.Stent damage can be seen on the cone-beam computed tomography (cbct).Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to address the reported failure mode.A review of the device history record (dhr) for lot 14695385 and the related subassembly lots found no nonconformances that could have contributed to the failure.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev 4 ¿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: 4.5 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.Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.Maintain wire guide position during delivery system insertion.Fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.As the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary.7.1 individualization of treatment: additional considerations for patient selection include, but are not limited to: patient¿s age and life expectancy co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) patient¿s suitability for open surgical repair.Patient¿s anatomical suitability for endovascular repair.The risk of aneurysm rupture compared to the risk of treatment with the zenith spiral-z aaa iliac leg.Patient¿s ability to tolerate general, regional, or local anesthesia.Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 14 french to 16 french vascular introducer sheath.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).Freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft.The final treatment decision is at the discretion of the physician and patient evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents suggest that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, expert review of still images provided by the facility, and the results of our investigation, a definitive cause for the failure could not be established.Patient anatomy and the procedure itself likely contributed to the reported event.The reviewer noted, the introducer tip was approximately at the level of the left small fenestration with aortic angulating inclining the introducer towards the affected side.The appropriate personnel have been notified.Per the 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 Description

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

Manufacturer Narrative

Correction: c (suspect products) additional information: d4: (lot number, expiration date, udi), h4.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.

• 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: 16753154
• MDR Text Key: 313432399
• Report Number: 1820334-2023-00444
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)250428(10)14695385
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-74-ZT
• Device Lot Number: 14695385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: COOK CUSTOM MADE GRAFT WITH FENESTRATIONS; LUNDERQUIST WIRE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female