MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-15 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[175025174]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175025175]
A heli-fx endoanchoring system was used in the endovascular treatment of the patient with a 87mm abdominal aortic aneurysm. The patient previously had a non mdt (e-tegra jotec) stent graft implanted a week previously and 8 endoanchors were implanted for the treatment of a type ia endoleak. It was reported that the endoleak was resolved after placement of the heli-fx endoanchors. It was reported that the patient had renal failure, diagnosed via blood testing 3 months later and that this was assessed by the investigator as related to the stent graft and heli-fx device. The patient had medication and a secondary intervention to implant a renal stent but this was unsuccessful and the event is unresolved. The cause of the event is undetermined. No additional clinical sequelae were reported and the patient is continuing with treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00228 |
| MDR Report Key | 9589954 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-01-11 |
| Date Added to Maude | 2020-01-15 |
| 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 Phone | 091708096 |
| 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 | 2020-01-15 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0008948311 |
| Device Expiration Date | 2020-01-11 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |