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 2020-01-20 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[176084574]
Medtronic received the following information from the journal article entitled; technical approach and outcomes of failed infrarenal endovascular aneurysm repairs rescued with fenestrated and branched endografts. Https://doi. Org/10. 1186/s42155-019-0075-z jesse manunga, larissa i. Stanberry, peter alden, jason alexander, nedaa skeik, elliot stephenson, jessica titus, joseph karam, xiaoyi teng and timothy sullivan cvir endovascular 2019 vol 2 issue 1. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176084575]
A talent abdominal aortic stent graft was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm on an unknown date. Heli-fx endoanchors were also implanted on an unknown date for endoleak repair. A re-intervention procedure was carried out for treatment failure using a non-mdt fenestrated stent graft. The indication for re-intervention was either a type ia endoleak, a type ib endoleak or endotension. The patient also may have presented with a rupture that required emergency re-intervention treatment failure of the initial evar were reported to be due to stent graft migration, disease progression, short initial neck or, unable to be determined. Abstract background endovascular rescue of failed infrarenal repair (evar) has emerged as an attractive option to stent graft explantation. The procedure, however, is underutilized due to limited devices accessibility and the challenges associated with their implantation in this patient population. The purpose of this study was to report our outcomes and discuss our approach to rescuing previously failed infrarenal endovascular aneurysm repairs (evar) with fenestrated/branched endografts (f/b-evar). Methods a retrospective analysis of prospectively collected data of consecutive patients with failed evar rescued with f/b-evar at our institution from november 2013 to march 2019 was conducted. The study primary end point was technical success; defined as the implantation of the device with no type i a/b or type iii endoleak orconversion to open repair. Secondary endpoints included major adverse events (maes), graft patency and reintervention rates. Results during this time, 202 patients with complex aortic aneurysms were treated with f/b-evar. Of these, 19 patients (male: 17, mean age 7 9??? 7? Years) underwent repair for failed evar. The median time from failed repair to f/b-evar was 48 (30, 60) months. Treatment failure was attributed to stent graft migration in 9 (47. 4%) patients, disease progression in 5 (26. 3%), short initial neck in 3 (15. 8%) and unable to be determined in 2 (10. 5%). Three patients were treated urgently with surgeon modified stent graft. Technical success was achieved in 18 patients (95%), including two who had undergone emergent repair for rupture. Seventy-two targeted vessels (97. 3%) were successfully incorporated. Sixteen (84. 2%) patients required a thoracoabdominal repair to achieve a durable seal. Major adverse events (maes) occurred in 3 patients (15. 7%) including paralysis and death in one (5. 3%), compartment syndrome and temporary dialysis in another and laparotomy with snorkeling of one renal and bypass of the other in the third patient. Median (iqr) hospital length of stay was 3 (2, 4) days. Late reintervention, primary target vessel patency and primary assisted patency rates were 5. 3%, 98. 6% and 100%, respectively. Conclusion implantation of f/b-evar in patients with failed previous evar is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00327 |
| MDR Report Key | 9606663 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-10-27 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-20 |
| 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 | 2020-01-20 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| 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 | 2020-01-20 |