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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number G48418
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/05/2015
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the user prepared the device as usual and inserted the delivery system from the right common femoral artery but resistance was met.He checked the sheath tip and found it was frayed.He replaced it with a back-up to complete the procedure.The patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Common Device Name
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
MDR Report Key6708526
Report Number1820334-2017-01932
Device Sequence Number1360862
Product Code MIH
UDI-Device Identifier10827002484181
UDI-Public(01)10827002484181(17)160401(10)4932223
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/12/2017
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
Operator of Device Health Professional
Device Model NumberG48418
Device Catalogue NumberTFFB-28-96-ZT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2017
Initial Report FDA Received Date07/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age85 YR
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