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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
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WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS Back to Search Results
Model Number G35375
Medical Device Problem Code Device Tipped Over (2589)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/18/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is being sent as a correction to initial mdr # 3005580113-2021-00138 for william cook (b)(4) fei# (b)(4) was inadvertently sent by the cook medical llc fei# (b)(4).Please remove mdr# 3005580113-2021-00138 as this information has already been reported under mdr# 3002808486-2021-01896.
 
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Brand Name
ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key12842924
Report Number3005580113-2021-00140
Device Sequence Number4608782
Product Code MIH
UDI-Device Identifier10827002353753
UDI-Public(01)10827002353753(17)240323(10)E4089517
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/23/2024
Device Model NumberG35375
Device Catalogue NumberZTA-P-46-179-W
Device Lot NumberE4089517
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/19/2021
Date Device Manufactured03/23/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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