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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
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WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY Back to Search Results
Model Number G32551
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
At the end of the procedure the physician looked at the graft and noted a leak and placed a cuff graft which worked.At the one month follow up a type iii endoleak was noted at what appears to be the crotch area of the graft.The physician will schedule a repair procedure.
 
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Brand Name
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
Manufacturer (Section D)
WILLIAM A. COOK AUSTRALIA, PTY LTD
95 brandl street
eight mile plains
brisbane QLD 4 113
AS  QLD 4113
MDR Report Key11029926
Report Number3005580113-2020-00463
Device Sequence Number13779886
Product Code MIH
UDI-Device Identifier10827002325514
UDI-Public(01)10827002325514(17)230915(10)AC1065656
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/17/2020
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 Date09/15/2023
Device Model NumberG32551
Device Catalogue NumberZFEN-D-12-28-76-C
Device Lot NumberAC1065656
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/23/2020
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/17/2020
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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