MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/13/2023
Type of Reportable Event	Death
Event or Problem Description
The patient presented to the emergency department of (b)(6) with abdominal pain.It was determined that the patient had an abdominal aortic aneurysm (aaa) rupture and required immediate intervention.The patient underwent an emergency endovascular aortic repair (evar) in the early morning of (b)(6) 2023.The cook zenith flex aaa endovascular graft bifurcated main body was successfully placed below the renal arteries in the target landing zone.Due to access tortuosity and calcification, the iliac limbs were extended bilaterally to cover the external iliac access complications.After the placement of the grafts, it was discovered that the zenith flex aaa endovascular graft bifurcated main body had a type 1a endoleak.Balloon inflation was repeated to address the endoleak.The endoleak persisted.A cook sales representative was present for the case.The cook sales representative confirmed the planned landing zone (over the renal arteries) of the zenith flex with z-trak aaa endovascular graft main body extension (esbe-36-50-zt) with the physician.The physician made the decision to proceed with the placement of the zenith flex with z-trak aaa endovascular graft main body extension (esbe-36-50-zt) in the zenith flex aaa endovascular graft bifurcated main body and covered the renal arteries.After the procedure the patient was transferred to the critical care recovery room where they coded and then expired.It was reported that renal failure did not contribute to the clinical outcome.The focus of this report is the zenith flex with z-trak aaa endovascular graft main body extension (esbe-36-50-zt) that was placed over the renal arteries during the procedure to address a type 1a endoleak.A separate report with the patient identifier (b)(6) will be submitted for the same patient that captures the type 1a endoleak on the zenith flex aaa endovascular graft bifurcated main body (tffb-32-82-zt).
Additional Manufacturer Narrative
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 or Problem Description
Additional information was provided on 04apr2023.The event was an emergent rupture with limited imaging.The aortic neck was described as angulated and short.A 46 coda balloon with hand inflation was used.Ballooning was completed in all overlaps and sealing stents.It is unknown if an autopsy report will be provided.A death certificate is not available for the investigation.The cause of death determined by the physician was a ruptured abdominal aortic aneurysm (aaa).The cook devices did not contribute to the patient's death.The device is not available for return at this time.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.It was determined through the investigation and additional information that the device zenith flex with z-trak aaa endovascular graft main body extension (esbe-36-50-zt, lot 14890313) was intentionally deployed above the renal arteries and there was no indication that the type ia endoleak persisted after the device was deployed.During the course of the investigation, it was reported by the physician that the patient's death was not related to the renal arteries being covered but was due to the pre-existing condition of a ruptured aneurysm.Therefore, the patient death is not due to use of the device.Event is no longer reportable.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION
• 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: 16636935
• Report Number: 1820334-2023-00339
• Device Sequence Number: 7234564
• Product Code: MIH
• UDI-Device Identifier: 10827002552101
• UDI-Public: (01)10827002552101(17)250810(10)14890313
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2025
• Device Model Number: N/A
• Device Catalogue Number: ESBE-36-50-ZT
• Device Lot Number: 14890313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 06/06/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/12/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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: COOK 46 CODA BALLOON CATHETER.; COOK TFFB-32-82-ZT, LOT 14425131.; COOK ZSLE-11-107-ZT, LOT 15068498.; COOK ZSLE-11-122-ZT, LOT 14425131.; COOK ZSLE-11-90-ZT, LOT 14879637.; COOK ZSLE-24-74-ZT, LOT 14382584.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Unknown