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

Model Number	G47493
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 15174867
• Report Number: 3005580113-2022-00090
• Device Sequence Number: 17695430
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2022
• Report Date (Section F): 08/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2022
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/05/2022