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 2020-02-25 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[188750165]
Additional information: the patient was being discharged from hospital four days later and it was reported when the patient got out of bed they collapsed suddenly, and cpr was performed. The patient subsequently expired. As per the physician the cause of death is unknown and there won? T be an autopsy performed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188750448]
Film evaluation summary: the reported proximal type ia endoleak was confirmed from the films provided; however the cause of the endoleak could not be determined. The anatomy at implant is unknown, and images during implant <(>&<)> earlier post-implant ct? S were not provided for comparison. Images were also not provided from the interventional procedure to treat the reported endoleak and so analysis of the in-vivo configuration of the endurant cuff or of the implanted heli-fx endoanchors could not be provided. Aneurysm expansion was confirmed to have occurred based on measurements provided from the index procedure and so it is possible that disease progression (neck dilatation) may have been the primary contributor to an observed type ia endoleak. Neck calcification may have also been a factor. A previous type ii endoleak, as seen from the coils having been placed in the aaa sac, may have also contributed to the aaa expansion. The cause of the residual type ia endoleak seen following implant of the aortic cuff and endoanchors, as well as the most recently reported aaa rupture, also could not be determined. It is possible that implanting within the dilated and calcified neck may have contributed to these events. Additional information: it was reported the patient presented to the er with a ruptured aneurysm approximately four weeks post the re-intervention. A chimney was placed in the left renal artery and a endurant aortic cuff etcf3636c49e was implanted up to the right renal and sma. A chimney was then placed into the sma and covered the right renal artery, sma, and celiac artery with a valiant navion vnmf4343c103e stent graft and then placed another valiant navion vnmf4040c103e more proximally. A final angiogram showed the ia endoleak had resolved and the sma and left renal were perfused. The patient was then extubated that night and reported to be in a stable condition the next morning. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00870 |
| MDR Report Key | 9750680 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0010019119 |
| 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 | 2020-02-25 |