MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® DISSECTION ENDOVASCULAR STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47493
Medical Device Problem Codes	Unintended System Motion (1430); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k): p180001.Investigation is still in progress.This report is required by the fda under 21cfr 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
Description of event according to initial reporter: the green trigger wire mechanism gave resistance as the operator attempted to remove it from the delivery system, causing the grey positioner to move and displace the stent distally by ~5mm as evidenced by live fluoro imaging.After removing the green trigger wire, the operators retracted the grey positioner (dilator system) until it married into the sheath as guided by live fluoro imaging with no evidence of stent movement.However, upon removing the entire delivery system (sheath and grey positioner) for a 16fr sheath exchange, the stent migrated distally by ~6cm until the stent was rested entirely on the aortic bi-furcation.Patient outcome: device was meant to be implanted but the stent migrated from desired landing location.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: due to resistance when attempting to remove the green trigger wire mechanism the positioner displaced, and the stent rested in the aortic bifurcation.Reportedly the stent was implanted with no adverse effects on the patient and reportedly no interventional procedure was performed due to this occurrence.No device was returned for analysis, as the ¿device has been implanted and delivery system was disposed off¿ and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the difficulties in withdrawing the trigger wire mechanism.The instructions for use supplied with the device specify how to withdraw the trigger-wire release mechanism in a continuous movement and not to rotate it, but appropriate actions have been taken to address the difficulties encountered.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.Cook medical will continue to monotir for similar events this report is required by the fda under 21cfr 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH® DISSECTION ENDOVASCULAR STENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15137870
• Report Number: 3002808486-2022-00909
• Device Sequence Number: 5614615
• Product Code: MIH
• UDI-Device Identifier: 10827002474939
• UDI-Public: (01)10827002474939(17)250322(10)E4238016
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 03/22/2025
• Device Model Number: G47493
• Device Catalogue Number: ZDES-36-180-US
• Device Lot Number: E4238016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/28/2022
• Date Device Manufactured: 03/22/2022
• 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: Required Intervention
• Patient Sex: Unknown