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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Renal Failure (2041)
Date of Event	02/13/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that an (b)(6) male patient died five days after placement of a zenith flex with spiral-z technology aaa endovascular graft iliac leg graft.During the index procedure on (b)(6) 2022, the patient received two zenith iliac leg grafts, a proximal fenestrated body graft, and a distal fenestrated body graft.The patient developed renal failure and abdominal pain, but refused to pursue dialysis.The patient died several days later on (b)(6) 2022.It is currently unclear if the zenith iliac leg grafts caused or contributed to the patient death.Additional information regarding the cause of death, procedure details, planning and sizing information, and pre-existing conditions has been requested but is currently unavailable.This report captures one zenith iliac leg graft.The other zenith iliac leg graft involved in this event is also captured under patient identifier (b)(6).
Additional Manufacturer Narrative
The zenith proximal fenestrated body graft and the zenith distal fenestrated body graft involved in this event are manufactured by william cook (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Correction: additional information was received on 06jun2022.The customer confirmed the reported issue of renal failure and subsequent death were not related to either of the implanted zsle leg grafts.There is no indication that the zsle leg grafts caused or contributed to the patient death.Therefore, this event no longer meets the definition of a complaint under fda 21 part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction as there is no indication of a zsle leg graft malfunction leading to an ae.No further reports under manufacturer report number 1820334-2022-00696 will be submitted.
Event or Problem Description
Additional information was received on 06jun2022.The customer confirmed the reported issue of renal failure and subsequent death were not related to either of the implanted zsle leg grafts.There is no indication that the zsle leg grafts caused or contributed to the patient death.

• 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
• 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: 14323212
• Report Number: 1820334-2022-00696
• Device Sequence Number: 5269836
• Product Code: MIH
• UDI-Device Identifier: 10827002552323
• UDI-Public: (01)10827002552323(17)220823(10)9962451
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 08/23/2022
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-13-74-ZT
• Device Lot Number: 9962451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZFEN-D-12-28-76-C.; ZFEN-P-2-34-122-R.; ZSLE-16-90-ZT.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Male