MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32541
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2022
Type of Reportable Event	Death
Event or Problem Description
The device would rotate 180 degrees every time it was advanced through the groin.Rotation was eventually corrected and graft deployment was begun.After opening the first two stents, the orientation rotated on the graft.Rotation of the entire system was performed.When the graft was now correctly oriented, the distal end of the graft was opened.Upon, opening the distal end, it was noted that the graft was wrapped around itself (like a candy wrapper).Cannulation of the fenestrations was performed for the arm through the scallop as the physician could not cannulate through the wrapped graft (from below).Therefore, cannulation was done through the arm.Upon removing, the gold trigger wire, the wire snapped.Hemostats were then used to grab the remainder of the wire that snapped from the gold knob.The black trigger wire also snapped at the hub and was unable to be pulled from the device.Therefore, the top cap could not be deployed.The operation was converted to an open procedure.The patient expired in the icu while at the hospital.
Additional Manufacturer Narrative
No part of the device was returned for investigation.Pre-operative imaging was returned for evaluation.The imaging was reviewed by the medical director and the following was determined: the imaging shows the pre-existing infrarenal aaa graft (endologix) in position; it also shows that the iliacs were fairly tortuous, particularly the left one which had a total angulation of about 90 degrees around the arc.This would not have required too much torque of the device ¿ they got the device into position ok.It¿s just that once in position in the aorta, the delivery system still had enough rotational torque to twist into a full ¿candy-wrapper¿ configuration.The medical director concluded ¿the surgeon¿s impression ¿ and one that i tend to agree with ¿ is that there must have been some rotational torque in the system, possibly from the loading procedure, which is stored as potential energy until the system is moved or manipulated.Then the stored torque causes the twisting." the following additional information was received: the device was inspected prior to use in order to ensure no damage has occurred.The device was positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation.The anterior/posterior markers formed a cross, and the tick marker appeared to be in the correct orientation.The anterior markers aligned with the tick mark when the gold markers were checked under fluoroscopy prior to insertion into the patient.The thumb screws (rmts) were aligned at 12 o¿clock and were aligned with the anterior gold markers.The gold markers on the graft aligned as per the ifu.The gold markers rotated as per the ifu pre-procedure.The following additional devices were used during the procedure: - pta balloon, steerable sheath, ansel sheath, gore dry-seal sheath, various wires and catheters.A cook representative was present for the case.No part of the procedure was performed off-label or out of the patient selection criteria.Difficulty was experienced during deployment.The patient¿s anatomy was not really tortuous.It was reported that the cause of death determined by the physician to be blood loss.It was confirmed that the device was not available for return.Review of device history record found work order (b)(4) appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformances raised or temporary deviations in place at the time of manufacture.There are a number of processes and checks in the specifications to ensure that the graft is loaded in the correct orientation within the delivery system.A review of the manufacturing records and specifications did not reveal any discrepancies that could have contributed to the reported issue.The investigation concludes the complaint device was manufactured to specification.The instructions for use (ifu) supplied with this device states: 10.2 'inspection prior to use' "inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient".11.4.5 'proximal body placement' "4.Before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers".¿caution: maintain wire guide position during delivery system insertions.Caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).¿ there is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined.Possible root cause(s) are: inadequate design, patient/procedural factors, operator error - valve twisted during transfer into sheath.A notification of this event was provided to manufacturing.
Event or Problem Description
The device would rotate 180 degrees every time it was advanced through the groin.Rotation was eventually corrected, and graft deployment was begun.After opening the first two stents, the orientation rotated on the graft.Rotation of the entire system was performed.When the graft was now correctly oriented, the distal end of the graft was opened.Upon, opening the distal end, it was noted that the graft was wrapped around itself (like a candy wrapper).Cannulation of the fenestrations was performed for the arm through the scallop as the physician could not cannulate through the wrapped graft (from below).Therefore, cannulation was done through the arm.Upon removing, the gold trigger wire, the wire snapped.Hemostats were then used to grab the remainder of the wire that snapped from the gold knob.The black trigger wire also snapped at the hub and was unable to be pulled from the device.Therefore, the top cap could not be deployed.The operation was converted to an open procedure.The patient expired in the icu while at the hospital.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA PTY LTD.; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113 ; 738411188
• MDR Report Key: 15223055
• Report Number: 9680654-2022-00015
• Device Sequence Number: 11958372
• Product Code: MIH
• UDI-Device Identifier: 10827002325415
• UDI-Public: (01)10827002325415(17)250617(10)AC1112891
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2025
• Device Model Number: G32541
• Device Catalogue Number: ZFEN-P-2-26-124-R
• Device Lot Number: AC1112891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/14/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Female