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 2020-03-03 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[181837502]
It was reported that in-stent restenosis occurred. The subject was enrolled in the (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day. The 95% stenosed target lesion was located in right distal superficial femoral artery (sfa). The target lesion was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion. Predilation was performed and a 6 mm x 150 mm study stent was implanted. Following post dilation, residual stenosis was 5%. On (b)(6) 2017, the subject was discharged. On (b)(6) 2019, the subject presented for the protocol specified 24 month follow-up visit. The subject was noted to have moderate stenosis in the stent on the right sfa. No action was taken to treat the event. At the time of reporting, the event was ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02380 |
| MDR Report Key | 9779795 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-10-30 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2016-09-12 |
| Date Added to Maude | 2020-03-03 |
| 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 | 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 | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-03 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0019834884 |
| Device Expiration Date | 2018-03-31 |
| 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. Other | 2020-03-03 |