MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-24 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[184805873]
Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10
[184805954]
It was reported that partial stent deployment occurred. A 6x120x130 eluvia self-expanding stent was selected for use in the 100% stenosed, non tortuous, and severe calcified superficial femoral artery (sfa). A contralateral approach was used and the lesion was pre-dilated with a 4mm sterling balloon. The angle of aorta was tight. The stent was advanced over a 0. 014 jupiter guidewire without replacing with 0. 035 guidewire inside a non-bsc 6 fr sheath. Stent deployment was initiated. When deployed about 6 cm, the thumbwheel stopped rotating, and the stent remained on the shaft. Then, the physician broke the handle, and pulled the inner shaft inside, and the stent was placed. There was section at about 1cm in the middle of the stent that the struts were wide open and the struts were stretched. There were no patient complications and the patient's condition was good post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03679 |
| MDR Report Key | 9871656 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-24 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-24 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |