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 2020-02-21 for ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM manufactured by Boston Scientific Corporation.
[180625379]
Date of the event is unknown, the first date of the month of the aware date was used.
Patient Sequence No: 1, Text Type: N, H10
[180625380]
It was reported that the stent was fractured. An eluvia self-expanding stent system was implanted. Approximately three years later, the patient presented with leg pain and imaging was done. A stent fracture was apparent in the imaging and some calcification was noted at the point of fracture. A second procedure was not yet performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01865 |
| MDR Report Key | 9738849 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-21 |
| 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 SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-02-21 |
| 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 | 2020-02-21 |