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 2020-03-24 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[184737879]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184737880]
It was reported that in-stent restenosis occurred. The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day. The target lesion was located in right distal superficial femoral artery (sfa) involving the popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm. It was classified as tasc ii b lesion. The target lesion was treated with pre-dilatation followed by direct placement of 7 mm x 100 mm and 7 mm x 80 mm study 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 was diagnosed with in-stent occlusion at the right distal sfa. On same day subject was hospitalized for further treatment and evaluation. There was 100% stenosis, which was 140 mm long with a reference vessel diameter of 5 mm. Thrombolysis treatment was performed. Post revascularization, the residual stenosis was 15%. On (b)(6) 2020, the event was considered recovered and resolved with sequelae and the subject was discharged on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03761 |
| MDR Report Key | 9872581 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0020986452 |
| Device Expiration Date | 2019-01-17 |
| 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 | 2020-03-24 |