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 2020-01-14 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[174927714]
Other relevant device(s) are: product id: sg-64, s/n:unknown; use by date: unknown, upn # unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174927715]
An endurant ii stent graft system was implanted in the endovascular treatment of a 59mm abdominal aortic aneurysm. During the index procedure an aortic cuff and endoanchors were also implanted. It is reported that the patient developed a fever post-op two days later. This was then treated with medication and the event resolved a day later. Another six days later, the patient suffered from dyspnea and abdominal pain. It was reported that the patient received treatment with medication, oxygenotherapy and a transfusion given. This fever event has been deemed by the sponsor to have a probable relationship to the procedure, not related to the devices, and not related to the aneurysm. The dyspnea and abdominalpain were assessed by the sponsor as possibly related to the procedure, not related to the devices and not related to the aneurysm. No additional clinical sequalae were reported and the patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
[182472502]
Associated products information; hg-16-62-28 ; s/n: (b)(4); use by date: 2020-01-03; upn # (b)(4), mfg date; 2018-01-03. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00219 |
| MDR Report Key | 9587526 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-06-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-02-08 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009583408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-14 |