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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number ZFEN-P-2-30-124-R
Device Problem Material Separation (1562)
Patient Problem Rupture (2208)
Event Date 09/12/2020
Event Type  Injury  
Event Description
Patient had z-fen repair in 2016.Follow up ct's showed abdominal aortic aneurysm (aaa) was shrinking per physician and then patient showed up in the emergency room with a ruptured aorta due to proximal and distal body graft overlap coming apart, and the two components were separated.They did not feel they could gain proximal control easily and opened the patient to repair.Proximal z-fen component stayed intact.Physician removed distal stent of proximal component and sewed aorta bifem to proximal.
 
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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 QLD 4 113
AS  QLD 4113
MDR Report Key10669125
MDR Text Key211320202
Report Number3005580113-2020-00422
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/09/2020,10/13/2020
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? No
Device Operator Health Professional
Device Catalogue NumberZFEN-P-2-30-124-R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/15/2020
Event Location Hospital
Date Report to Manufacturer10/09/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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