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 2020-01-09 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[188345360]
Additional information received: it was confirmed that the type ia endoleak was noted on a post-op cta. The completion run during the index procedure did not show any endoleak. The endoleak was planned to be reevaluated on ultrasound but the patient was lost to follow up due to other medical conditions. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188996177]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188996178]
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 72mm diameter abdominal aortic aneurysm. The aortic neck diameter ranged from 29 -31mm and was 7mm in length. The proximal neck angulation was 48 degrees. 4 heli-fx endoanchors were also used in the patient due to concern for late failure. It was reported that there was a type ia endoleak observed on completion of the procedure. The cause of the event is unknown no additional clinical sequelae were reported and the patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00159 |
| MDR Report Key | 9568072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009770069 |
| 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 | 2020-01-09 |