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 2020-03-27 for ENDURANT II EXTENSION CUFF ETCF3636C49E manufactured by Medtronic Ireland.
[186750856]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186750857]
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 55mm abdominal aortic aneurysm. It was reported that during the index procedure, the final angiogram showed a type ia endoleak was present. It was suspected as per the physician that three of the suprarenal stents appeared to be stuck together causing the graft to in fold causing a type 1 leak. An endurant aortic cuff etcf3636c49e was then implanted as treatment for the endoleak. This cuff appeared to partially cover the right renal artery. It was reported then the physician easily cannulated the right renal artery and placed a 6x18mm non mdt stent. The type ia endoleak had resolved and good flow was achieved in the right renal artery. As per the physician the cause of the event can not be determined. No additional clinical sequalae were provided and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01376 |
| MDR Report Key | 9888465 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-04-03 |
| Date Added to Maude | 2020-03-27 |
| 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 EXTENSION CUFF |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-25 |
| Model Number | ETCF3636C49E |
| Catalog Number | ETCF3636C49E |
| Device Expiration Date | 2020-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Other; 2. Required No Informationntervention | 2020-03-27 |