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 2020-01-02 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[186734535]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186734536]
A heli-fx endoanchor system was used for the endovascular treatment of a patient. It was reported during the index procedure that the cassette was missing three endoanchors. It was also reported that one endoanchor dislodged during the procedure and tracked into the patient's left renal artery. As per the physician the cause of the event was related to patient anatomy. The physician reported that the patient had a very short aortic neck with a large angle. No additional clinical sequalae was reported and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[188281018]
Additional information received; it was confirmed that the dislodged endoanchor is still in the renal artery. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00013 |
| MDR Report Key | 9537587 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-02-21 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009606200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-02 |