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.
[182397572]
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
[182397573]
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
| Report Number | 9612164-2020-00333 |
| MDR Report Key | 9606895 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-10-27 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-20 |
| 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 |
| Manufacturer Country | IE |
| Manufacturer Phone | 091708096 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| 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 | 2020-01-20 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-20 |