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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 DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number G32551
Device Problem Material Separation (1562)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Approximately three years post implant, the bifurcated graft separated from the tube graft.The physician had to reline the endograft.
 
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Brand Name
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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 Key14187042
MDR Text Key289875345
Report Number3005580113-2022-00049
Device Sequence Number1
Product Code MIH
UDI-Device Identifier10827002325514
UDI-Public(01)10827002325514(17)200808(10)AC1001202
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/22/2022
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? No
Device Operator Health Professional
Device Expiration Date08/08/2020
Device Model NumberG32551
Device Catalogue NumberZFEN-D-12-28-76-C
Device Lot NumberAC1001202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2022
Distributor Facility Aware Date04/01/2022
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer04/22/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2022
Date Device Manufactured08/08/2017
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 Age65 YR
Patient SexMale
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