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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number G36166
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The free flow did not open when the zenith renu aaa ancillary graft converter was ready to release, so the device had to be "retired" immediately.The device was being used for an aaa (abdominal aortic aneurysm) repair, and there were no reported serious injuries to the patient as a result of the product problem.
 
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Brand Name
ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
Type of Device
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7602465
MDR Text Key112166103
Report Number1820334-2018-01812
Device Sequence Number1
Product Code MIH
UDI-Device Identifier10827002361666
UDI-Public(01)10827002361666(17)161217(10)5509000
Combination Product (y/n)N
Reporter Country CodePE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/14/2018
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? Yes
Device Operator Health Professional
Device Model NumberG36166
Device Catalogue NumberAX1-1-28-125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age90 YR
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