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 2020-02-12 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Cardiovascular Santa Rosa.
[178739278]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178739279]
Non-mdt stent grafts were implanted in the endovascular repair of abdominal aortic aneurysm. A type ia endoleak was present at the end of this procedure. A secondary procedure was carried out where 10 endoanchors were successfully implanted due to the observed ia endoleak. It was confirmed that the type ia endoleak was present at the end of this procedure. Just over six months later, it was reported that there was a persistent type ia endoleak present. It was assessed as having a causal relationship to the index procedure. This endoleak was reported to have resolved with treatment on the same date when an additional procedure was performed and a non-mdt thoracic stent graft, an endurant aortic cuff, a chimney graft and two renal stents (non-mdt) were implanted. No cause of the event has been reported. No additional clinical sequelae were provided and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953200-2020-00004 |
| MDR Report Key | 9699069 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2020-02-12 |
| 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 CARDIOVASCULAR SANTA ROSA |
| Manufacturer Street | 3576 UNOCAL PLACE |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| 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 | 2020-02-12 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 50170025 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
| Manufacturer Address | 3576 UNOCAL PLACE SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |