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 2020-02-25 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180809396]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180809397]
Eminent clinical trial it was reported that in-stent restenosis occurred. The patient underwent treatment with the study stent on (b)(6) 2017 as part of the eminent clinical trial. The target lesion was located in the left mid superficial femoral artery (sfa) with 80% stenosis and was 70 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm and was classified as a tasc ii a lesion. The target lesion was predilated and a 6 mm x 100 mm, 75cm eluvia drug-eluting vascular stent was implanted. Following post dilation, residual stenosis was 0%. On (b)(6) 2017, the patient was discharged with antiplatelet therapy. On (b)(6) 2020, the patient was noted to have restenosis in the stent on the left leg. Angiography without revascularization was performed. On (b)(6) 2020, the patient was hospitalized for treatment of in-stent restenosis. On (b)(6) 2020, the patient eventually underwent revascularization on the same day. The event was considered resolved. On (b)(6) 2020, the patient was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02000 |
| MDR Report Key | 9750185 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2016-08-03 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0019635397 |
| Device Expiration Date | 2018-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-25 |