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	G32537
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A fenestrated [evar] endovascular repair was performed on an 82-year-old female patient with a zenith fenestrated aaa endovascular graft proximal body.The right renal fenestration did not open, even after ballooning (used a cook medical coda balloon) while attempting to cannulate.May be the two middle gold markers had stuck together.After some manipulation the stent eventually deployed, however, lost function to right renal as the graft covered the renal branch.The physician also stated could not get an.014 wire through the right renal branch of the graft.Additional devices implanted during procedure: endologic main body afx gore vbx 6x29 stent in the sma atrium medical icast 6x22 stent in the left renal artery.

• 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 ; AS
• MDR Report Key: 16025917
• Report Number: 3005580113-2022-00140
• Device Sequence Number: 5643563
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)251018(10)AC1119801
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2022
• Report Date (Section F): 12/21/2022

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: 10/18/2025
• Device Model Number: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1119801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2022
• Date Device Manufactured: 10/18/2022
• 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 Age: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/21/2022