MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS COOK; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47467
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While unsheathing graft to begin fenestrations, surgeon had difficulty getting graft to come out.When graft finally unsheathed, surgeon noticed that part of deployment system was broken rendering system unusable.

• Brand Name: COOK
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE APS; 750 daniels way; bloomington IN 47404
• MDR Report Key: 19220094
• Report Number: 19220094
• Device Sequence Number: 6960990
• Product Code: MIH
• UDI-Device Identifier: 10827002474670
• UDI-Public: (01)10827002474670(17)260808(30)1(10)E4409188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2024
• Report Date (Section F): 02/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G47467
• Device Catalogue Number: ZDEG-PT-32-202-PF-US
• Device Lot Number: E4409188
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 02/09/2024