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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
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The proximal and distal pieces have separated, creating an endoleak.The physician placed a bridging piece (an alpha thoracic piece) to bridge the separation successfully.
 
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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 Key11035919
Report Number3005580113-2020-00467
Device Sequence Number11089633
Product Code MIH
UDI-Device Identifier10827002325514
UDI-Public(01)10827002325514(17)201213(10)AC1008608
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/18/2020
Report Date (Section F) 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 Date12/13/2020
Device Model NumberG32551
Device Catalogue NumberZFEN-D-12-28-76-C
Device Lot NumberAC1008608
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/06/2020
Event Location Hospital
Date Report to Manufacturer12/17/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/18/2020
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 Age83 YR
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