ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85

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 2020-01-20 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.

Event Text Entries

[176779676] Medtronic received the following information from the journal article entitled; technical approach and outcomes of failed infrarenal endovascular aneurysm repairs rescued with fenestrated and branched endografts. Https://doi. Org/10. 1186/s42155-019-0075-z jesse manunga, larissa i. Stanberry, peter alden, jason alexander, nedaa skeik, elliot stephenson, jessica titus, joseph karam, xiaoyi teng and timothy sullivan cvir endovascular 2019 vol 2 issue 1. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[176779677] A talent abdominal aortic stent graft was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm on an unknown date. Heli-fx endoanchors were also implanted on an unknown date for endoleak repair. A re-intervention procedure was carried out for treatment failure using a non-mdt fenestrated stent graft. The indication for re-intervention was either a type ia endoleak, a type ib endoleak or endotension. The patient also may have presented with a rupture that required emergency re-intervention treatment failure of the initial evar were reported to be due to stent graft migration, disease progression, short initial neck or, unable to be determined.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-00316
MDR Report Key9606456
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-20
Date of Report2020-01-20
Date of Event2019-10-27
Date Mfgr Received2020-01-02
Date Added to Maude2020-01-20
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 ContactALISON SWEENEY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Manufacturer Phone091708096
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO ANCHOR SYSTEM - HELI-FX AAA
Generic NameENDOVASCULAR SUTURING SYSTEM
Product CodeOTD
Date Received2020-01-20
Model NumberSA-85
Catalog NumberSA-85
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY IE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-20

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