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 2020-03-12 for EPIC VASCULAR 39200 manufactured by Boston Scientific Corporation.
[183128100]
Age at time of event: above 18 years and older.
Patient Sequence No: 1, Text Type: N, H10
[183128101]
It was reported that stent positioning difficulties were encountered requiring an additional stent to be placed. The target lesion was located in the superficial femoral artery (sfa). A 7x40x120mm epic vascular stent was advanced for treatment. During the procedure, the stent jumped forward passed the stenosis after it was almost fully deployed. Another of the same stent was used to stent the stenosis. No patient complications were reported and no harm was done to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02885 |
| MDR Report Key | 9823325 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-12 |
| 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 CORPORATION |
| 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 | EPIC VASCULAR |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-12 |
| Model Number | 39200 |
| Catalog Number | 39200 |
| Lot Number | 0024657456 |
| 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 | 1. Required No Informationntervention | 2020-03-12 |