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	Malposition of Device (2616)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: patient came in for a dissection emergent case.During deployment or user aggression the graft landed distal to where the actual approx landing zone wanted to be ((b)(4)).The physician decided to use a device from another manufacturer to get more of a proximal seal, delivered the device then distality he extended out the zdes-36-180-us upon final run he was satisfied with the final angio.Fast forward to recently within the last week the patient had to come back in with a type a dissection to where they had to build the arch ((b)(4)).Patient outcome: the patient was prolonged hospitalized for recovery.Furthermore, the patient had to return for complete arch repair.

• 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: 16136975
• Report Number: 3005580113-2023-00001
• Device Sequence Number: 20517395
• Product Code: MIH
• UDI-Device Identifier: 10827002474939
• UDI-Public: (01)10827002474939(17)240914(10)E4158918
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2023
• Report Date (Section F): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: G47493
• Device Catalogue Number: ZDES-36-180-US
• Device Lot Number: E4158918
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2022
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2023
• Date Device Manufactured: 09/14/2021
• 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: Female
• Date Report Sent to FDA: 01/06/2023