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 2020-03-04 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[183121649]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183121650]
A heli-fx endoanchoring system was used in conjunction with the implantation of a non-mdt stent graft in the endovascular treatment of a 68 thoracic aortic aneurysm. It was reported that 10 endoanchors were successfully implanted due to a concern for late failure of the non-mdt stent graft. It was reported that on the same date of the index procedure the patient was hypotensive. This hypotension was resolved with medication four days post the index procedure and recovered with treatment. Two days post the index procedure the patient suffered from bleeding, anemia and a cardiac arrhythmia. This cardiac arrhythmia was resolved with medication on same date it was diagnosed. The bleeding and anemia was resolved three days later and the patient received 1 unit of packed blood cells. The hypotension, anemia/bleeding and cardiac arrhythmia events were all assessed by the sponsor as having a causal relationship to the procedure and not related to the endoanchor helix-fx device. The site assessed these events as related to the index procedure. No cause of the events have been reported. No additional clinical sequalae were provided and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01014 |
| MDR Report Key | 9786538 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009087540 |
| 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 | 2020-03-04 |