GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS manufactured by W.l. Gore & Associates.

MAUDE Entry Details

Report Number2017233-2020-00163
MDR Report Key9802545
Date Received2020-03-06
Date of Report2020-02-07
Date of Event2019-08-05
Date Added to Maude2020-03-06
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 ContactSIBYLLE STAERK
Manufacturer Street1500 N. 4TH STREET
Manufacturer CityAZ
Manufacturer Phone9285263030
Manufacturer G1MEDICAL ECHO RIDGE B/P
Manufacturer Street3250 W. KILTIE LANE
Manufacturer CityFLAGSTAFF AZ 86005
Manufacturer CountryUS
Manufacturer Postal Code86005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Generic NameSTENT, ILIAC
Product CodeNIO
Date Received2020-03-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerW.L. GORE & ASSOCIATES
Manufacturer AddressFLAGSTAFF AZ


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-06

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