GORE VIATORR? TIPS ENDOPROSTHESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.

Event Text Entries

[112360867] The article stated the average age for group a was 63. 6, therefore 64 will be used for patient age. The article stated that for group a 75% were female, therefore female will be used as patient gender. Patient weight requested but not provided. Date of event used is the date article published, (b)(6) 2018. As exact date is unknown, (b)(6) 2018 will be used. Modha k, kapoor b, lopez r, sands m, and carey w. Symptomatic heart failure after transjugular intrahepatic portosystemic shunt placement: incidence, outcomes, and predictors. Cardiovasc intervent radiol (2018) 41:564? 571.
Patient Sequence No: 1, Text Type: N, H10


[112360868] This information was received through literature article "symptomatic heart failure after transjugular intrahepatic portosystemic shunt placement: incidence, outcomes, and predictors" published in cardiovascular interventional radiology: april 2018 the articles objective is to assess the incidence of symptomatic heart failure (shf) occurring after transjugular intrahepatic portosystemic shunt (tips) placement, identify potential predictors of shf, and evaluate clinical presentation and outcomes in cases of post-tips shf. Shf was defined as otherwise unexplained new-onset dyspnea, hypoxemia (oxygen saturation of <92 mm hg on pulse oximetry or arterial partial pressure of oxygen <80 mm hg), radiologic pulmonary edema, new/increased need for diuretics, and/or need for intubation within 7 days of tips placement. The article reports that a prospectively maintained tips database was used to identify patients who underwent new tips placements at a large urban tertiary care center between 1995 and 2014. A total of 882 patients were in the final study group. The article reports that eight patients (0. 9%) developed shf, usually manifested by hypoxemia (50%) or dyspnea (25%) within 48 hours. Two of the eight patients required intubation post tips procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007284313-2018-00188
MDR Report Key7638505
Date Received2018-06-26
Date of Report2018-06-07
Date of Event2018-04-01
Date Added to Maude2018-06-26
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 ContactKATHY TITUS
Manufacturer Phone9285263030
Manufacturer G1MEDICAL PHOENIX 1 B/P
Manufacturer Street32360 N. NORTH VALLEY PARKWAY
Manufacturer CityPHOENIX AZ 85085
Manufacturer CountryUS
Manufacturer Postal Code85085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGORE VIATORR? TIPS ENDOPROSTHESIS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Product CodeMIR
Date Received2018-06-26
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; 2. Required No Informationntervention 2018-06-26

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