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 2020-03-30 for ENDURANT II BIFURCATED STENT GRAFT ETBF2513C166E manufactured by Medtronic Ireland.
[189092043]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189092044]
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm. It was reported that a ct performed two years and six months later showed a type ia endoleak was present. As per the physician the cause of the event is disease progression. No additional clinical sequalae were provided and the patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01404 |
| MDR Report Key | 9898027 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2017-04-13 |
| Date Added to Maude | 2020-03-30 |
| 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 | ENDURANT II BIFURCATED STENT GRAFT |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-30 |
| Model Number | ETBF2513C166E |
| Catalog Number | ETBF2513C166E |
| Device Expiration Date | 2019-04-13 |
| 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 | 2020-03-30 |