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 2020-03-30 for ENDURANT II BIFURCATED STENT GRAFT ETBF3216C166EJ manufactured by Medtronic Ireland.
[186763302]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186763303]
An endurant ii bifurcated stent graft system was implanted in a patient for the endovascular treatment of a 77mm abdominal aortic aneurysm. Four non-mdt stent grafts were also implanted during the procedure. It was reported that ct performed six days later, showed that the non-mdt left limb had completely separated from the main stent graft body, even though an overlap of three stents was performed at the time of the index procedure. A secondary intervention was carried out and bridging was performed between the limb of the main stent graft body and the detached stent graft limb. It was confirmed that the endoleak resolved and the procedure was completed. As per the physician, the cause of the event was due to patient anatomy. The patient? S common iliac artery was reported to be severely tortuous and it was thought that when the wire was removed during the index procedure the limb separated when the vascular morphology returning to normal. No additional clinical sequelae were reported and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01393 |
| MDR Report Key | 9896767 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-12-18 |
| 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 | ETBF3216C166EJ |
| Catalog Number | ETBF3216C166EJ |
| 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 | 2020-03-30 |