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 2020-02-17 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[188636565]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188636840]
It was confirmed that the cause of user error was given for the endoanchor event, it was reported that the physician felt he did not achieve appropriate penetration during phase one deployment of the embolic endoanchor. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189010274]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189010275]
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 71mm abdominal aortic aneurysm. It was reported that during the index procedure, the endovascular repair was performed without complication. It was noted that on final angiogram a endoleak was present. The physician decided to place endoanchors at the proximal seal zone to treat the endoleak. It was reported that four endoanchors were deployed in a good position. It was reported that multiple attempts were made to implant the 5th endoanchor but it did finally deploy. When the physician was deploying the 6th endoanchor, it was noted that the 5th endoanchor had dislodged and was no longer in position. Multiple attempts were made to retrieve this endoanchor and it successfully was retrieved with a snare catheter and then removed. A final angiogram showed the type ia endoleak was still present. As per the physician the cause of the event is user error. No additional clinical sequalae were provided and the patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00748 |
| MDR Report Key | 9716853 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-12-19 |
| Date Added to Maude | 2020-02-17 |
| 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 | 2020-02-17 |
| Returned To Mfg | 2020-02-13 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0010068546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-02-17 |