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 2020-03-10 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[182795720]
Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182795721]
(b)(6) clinical study. It was reported that in-stent stenosis occurred. The subject underwent treatment with a study device on (b)(6) 2019 as part of the eminent clinical trial. The target lesion was located in the left proximal superficial femoral artery (sfa) with 80% stenosis. The lesion was 90 mm long with a proximal and distal reference vessel diameter of 4 mm and was classified as a tasc ii b lesion. The target lesion was treated with direct placement of the 6 mm x 100 mm stent. Following post dilation, residual stenosis was 0%. On (b)(6) 2019, the subject was discharged with antiplatelet therapy. On (b)(6) 2020, the subject presented for the 12-month follow-up visit. Duplex ultrasound was performed which revealed about 70 % in stent stenosis at the left superficial femoral artery. No action was taken to treat the event. The event was considered as not recovered/not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02782 |
| MDR Report Key | 9811860 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2020-03-10 |
| 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 | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-10 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0021649776 |
| Device Expiration Date | 2019-06-19 |
| 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. Other | 2020-03-10 |