MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study, report with the FDA on 2020-02-04 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[177771426]
Other relevant device(s) are: sg-64, lot number unknown, use by date: unknown, upn # unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177771427]
An endurant ii stent graft system was implanted in the endovascular treatment of a 95mm abdominal aortic aneurysm. During this procedure a heli -fx endoanchoring system was used and seven endoanchors were implanted. During the index procedure it was reported that the patient was hypotensive, bleeding and anemic. It was reported that the patient had an estimated blood loss of 400mls. This was then treated and the patient received an infusion of 2 units of red blood cells, was given medication and had diagnostic imaging performed. This event was reported to have resolved four days later and the patient recovered with treatment. This event has been assessed by the site as being related to the index procedure.
Patient Sequence No: 1, Text Type: D, B5
[182473471]
It was confirmed that the endoanchors were used in this procedure for both a concern for late failure and for a type ia endoleak. It was reported that four endoanchors were used to secure the trunk due to a short angulated neck and a further three endoanchors were implanted as a final arteriogram demonstrated a persistent flow coming from the right lateral aspect of the device which was confirmed to be the ia endoleak. Final arteriogram showed the endoleak had resolved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00534 |
| MDR Report Key | 9663862 |
| Report Source | COMPANY REPRESENTATIVE,STUDY, |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-27 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALISON SWEENEY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY MN |
| Manufacturer Country | IE |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO ANCHOR SYSTEM - HELI-FX AAA |
| Generic Name | ENDOVASCULAR SUTURING SYSTEM |
| Product Code | OTD |
| Date Received | 2020-02-04 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 45033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |