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 2020-03-19 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[184163738]
Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184163739]
(b)(6) clinical study. It was reported that intra-stent stenosis occurred. The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial. The target lesion was located in right distal superficial femoral artery (sfa) with 100% stenosis. The lesion was 40 mm long with a proximal and distal reference vessel diameter of 6 mm and was classified as a tasc ii b lesion. The target lesion was treated with pre-dilatation and placement of the 6 mm x 40 mm stent. Following post dilation, the residual stenosis was 0%. On (b)(6) 2017, the subject was discharged with antiplatelet therapy. On (b)(6) 2019, the subject presented with recurrent lameness in the right lower limb and was hospitalized for further evaluation and treatment. Diagnostics revealed extensive intra-stent stenosis in the right lower limb and revascularization was recommended. On (b)(6) 2019, an unknown percentage of stenosis in the target lesion was treated with the placement of a stent. The residual stenosis is unknown (tvr). On (b)(6) 2019, the subject was discharged on antiplatelet medications. The event is considered recovering/resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03507 |
| MDR Report Key | 9853447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2017-02-16 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0020370967 |
| Device Expiration Date | 2018-08-15 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-19 |