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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 G32554
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The zfen was placed (b)(6) 2020.Leak was thought to be potential type ll and we would re-evaluate.30 day ct follow up was performed and significant endoleak was still appreciated.Diagnostic angiograms confirmed type lll, thought to be tear of defect in flow divider.Patient was rescheduled to reline.
 
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Brand Name
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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 QLD 4 113
AS  QLD 4113
MDR Report Key10777641
Report Number3005580113-2020-00439
Device Sequence Number14292513
Product Code MIH
UDI-Device Identifier10827002325545
UDI-Public(01)10827002325545(17)230708(10)AC1062091
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/03/2020
Report Date (Section F) 11/02/2020
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
Operator of Device Health Professional
Device Expiration Date07/08/2023
Device Model NumberG32554
Device Catalogue NumberZFEN-D-12-28-91-C
Device Lot NumberAC1062091
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/07/2020
Event Location Hospital
Date Report to Manufacturer11/02/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
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