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 2020-03-06 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[182472808]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182472809]
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of 60mm abdominal aortic aneurysm. A heli-fx endoanchoring system was also used for the prevention of neck dilation and 10 endoanchors were deployed. At the end of this procedure it was noted that a type ia endoleak was present. This endoleak was assessed as related to the index procedure and was judged to have resolved without treatment two months later. A new type ia endoleak was observed on the just over four years post the index procedure via ct and ultrasound which was judged by the site as not related. A secondary endovascular procedure was completed using the snorkel technique and an aortic extension cuff implanted which resolved this event thirteen days later. This endoleak was assessed by the site as not related to the study procedure and probably related to the study device. No cause of the event was reported. No additional clinical sequalae were provided and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01042 |
| MDR Report Key | 9796644 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 481560000 |
| 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 | 2020-03-06 |