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 2020-02-27 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.

Event Text Entries

[188752564] Film evaluation summary: the reported endoleak seen during the interventional procedure was confirmed; however, the exact cause/source of the endoleak observed by the physician could not be determined from the films returned. Lack of films from the index procedure showing the endoleak did not allow assessment of the event prior to and post implantation of the endurant cuff. Lack of pre-implant ct? S did not allow for a thorough assessment of the pre-implant anatomy. Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult. The reported type ia endoleak appears likely. The exact cause could not be determined but may have been related to the aortic neck angulation observed or due to other unknown neck anatomical issue(s). No obvious stent graft issues could be identified that could be a cause of a type ia endoleak. It is likely that an acute type iv blush endoleak caused by fabric porosity was also present. This likely type iv appeared as focused leak from the flow divider that is most likely due to the higher porosity in that portion of the stent graft distal to the overlap of the bifurcate and cuff. Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this likely type iv endoleak. Films from the reported aaa rupture event where the physician completed bilateral renal chimney stents and extended proximally with an endurant aortic cuff were not available for review. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612164-2020-00897
MDR Report Key9762220
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-27
Date of Report2020-03-10
Date of Event2019-08-23
Date Mfgr Received2020-02-28
Date Added to Maude2020-02-27
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 Phone091708096
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
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 Received2020-02-27
Returned To Mfg2020-02-07
Model NumberSA-85
Catalog NumberSA-85
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-27

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