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 2020-03-26 for ENDURANT II BIFURCATED STENT GRAFT ETBF3216C166E manufactured by Medtronic Ireland.
[186747503]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186747504]
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm. It was reported that the patient had previously been treated with coils for a type ii endoleak but the aneurysm was still growing. Ct approximately three years post the index procedure showed possible type ib endoleak at the left iliac seal zone. An aortogram confirmed the presence of a type ib endoleak. An endurant ii stent graft limb etew2020c82e was implanted as treatment into the existing bifurcated ispsi leg to extend to the hypogastric artery. Ballooning was carried out and another aortogram showed the endoleak had resolved. As per the physician, the cause of the event cause was continued dilatation of the common iliac artery. No additional clinical sequelae were reported and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01359 |
| MDR Report Key | 9882258 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | ETBF3216C166E |
| Catalog Number | ETBF3216C166E |
| Device Expiration Date | 2018-07-12 |
| 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 | 2020-03-26 |