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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
Model Number G32549
Medical Device Problem Code Separation Problem (4043)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
As stated by the initial reporter "the two grafts separated from one another." they are scheduled for a esbe or tx2 dissection stent to bridge the gap (intervention procedure is scheduled to take place 'next week'.
 
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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 QLD 4 113
AS  QLD 4113
MDR Report Key9963818
Report Number3005580113-2020-00352
Device Sequence Number2740681
Product Code MIH
UDI-Device Identifier10827002325491
UDI-Public(01)10827002325491(17)200516(10)AC995888
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/15/2020
Report Date (Section F) 04/14/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date05/16/2020
Device Model NumberG32549
Device Catalogue NumberZFEN-P-2-34-137-R
Device Lot NumberAC995888
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/09/2020
Event Location Hospital
Date Report to Manufacturer04/14/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/15/2020
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;
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