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

Device Problem Difficult to Open or Close (2921)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/14/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 305933775
• Report Number: 3005580113-2022-00140
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 12/21/2022
• Distributor Facility Aware Date: 12/14/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female