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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number G47457
Medical Device Problem Codes Positioning Failure (1158); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/17/2020
Type of Reportable Event Serious Injury
Event or Problem Description
According to the initial reporter: "green trigger wire was difficult to pull out, and when it was pulled out the graft migrated back; device was removed from patient, and another graft (alpha) had to be placed in the originally intended location.The third graft was already planned as part of the procedure.Dm believes adhesive may have been a contributing factor (like it was stuck together).".
 
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Brand Name
ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Common Device Name
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key9987941
Report Number3005580113-2020-00353
Device Sequence Number3836369
Product Code MIH
UDI-Device Identifier10827002474571
UDI-Public(01)10827002474571(17)220819(10)E3886709
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/22/2020
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 Date08/19/2022
Device Model NumberG47457
Device Catalogue NumberZDEG-P-38-154-PF-US
Device Lot NumberE3886709
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/20/2020
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/22/2020
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 Life Threatening; Required Intervention;
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