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 Pain (1994)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

E1: address: (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 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

Cook was notified of a type 1b endoleak on a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The patient was diagnosed with an abdominal aortic aneurysm (aaa) that measured 53 mm.Imaging was completed in 2017 to plan and size for the devices to be placed in an endovascular aortic repair (evar).The aaa measured 55 mm.The landing zone to the renal arteries measured 15 mm.There was not significant aortic angulation.The distal aorta measured 20 mm in diameter.There was mild to moderate tortuosity from the common iliac arteries (cia) to the external iliac arteries.The common femoral artery (cfa) to the skin measured 28 mm bilaterally.No bifurcation occurred at the same level.No calcification was present.It was determined that standard evar was feasible per instructions for use and the peri-procedural technical risk was low.A total percutaneous endovascular aneurysm repair (pevar) was determined to be a possible treatment option.The patient was treated on (b)(6) 2017 for an abdominal aortic aneurysm (aaa) that measured 53 mm.The neck anatomy was described as parallel.The patient's anatomy was determined to be within the instructions for use (ifu) for the cook devices.He underwent endovascular aortic repair where a cook zenith low profile aaa endovascular graft main body and bilateral cook zenith flex with spiral-z technology aaa endovascular graft iliac legs were implanted.The patient was not compliant with follow up imaging protocols.The patient presented six years after the evar procedure with an asymptomatic aneurysm that had expanded to 85 mm.It was reported that the bare proximal struts of the cook zenith low profile aaa endovascular graft main body broke from the grafted segment of the device.The patient did not have a surgical option to explant the device.Therefore, a fenestrated device was urgently requested.It was reported that an emergent fenestrated endovascular aortic repair would be required to reline the device.During the investigation of the report of the broken proximal struts of the cook zenith low profile aaa endovascular graft main body an imaging review was completed.During the imaging review it was discovered that there was a type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg.The focus of this report is the type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg.

• 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: 19041199
• MDR Text Key: 339436692
• Report Number: 1820334-2024-00461
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-13-74-ZT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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 RPN: CODA-2-9.0-35-120-32.; COOK RPN: TSCMG-35-260-E-LESDC.; COOK RPN: ZALB-26-84, LOT 7392463.; COOK RPN: ZSLE-13-74.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG