ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT ZFV6-80-10-8.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT ZFV6-80-10-8.0 manufactured by Cook Ireland Ltd.

MAUDE Entry Details

Report Number3001845648-2020-00155
MDR Report Key9824340
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-02-14
Date of Event2020-02-14
Date Facility Aware2020-02-14
Date Mfgr Received2020-02-17
Device Manufacturer Date2019-05-16
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. HEATHER RYAN
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Manufacturer G1COOK IRELAND LTD
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Generic NameNIO STENT, ILIAC
Product CodeNIO
Date Received2020-03-12
Catalog NumberZFV6-80-10-8.0
Lot NumberC1613250
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age274 DA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK IRELAND LTD
Manufacturer AddressO HALLORAN ROAD LIMERICK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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