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 2020-03-04 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[182154345]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182154346]
An endurant stent graft system was in a patient for the endovascular treatment of a 53mm abdominal aortic aneurysm. 10 heli-fx endoanchors were also deployed during the procedure for prevention of neck dilatation and due to an observed type ia endoleak. It was noted that the endoanchors did not resolve the type ia endoleak. The investigator assessed the endoleak as procedure related. A ct was completed just over a month later and the type ia endoleak was still present. This type ia endoleak has been assessed by the site as being probably related to the index procedure, possibly related to the device (uncertain which device). This event has been assessed by the sponsor as being probably related to the study procedure, having a causal relationship to the study device. A secondary endovascular procedure was performed a further three months later and the patient successfully had a coil embolization completed. Th event is reported to have resolved with this treatment the patient was discharged the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00989 |
| MDR Report Key | 9784788 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-08-07 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| 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 | 2020-03-04 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009690965 |
| 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 | 2020-03-04 |