MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-25 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180809728]
Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180809729]
(b)(6) clinical study. It was reported that restenosis occurred. The subject was enrolled in the emient study on (b)(6) 2017 and the index procedure was performed on the same day. The target lesion was located in right mid superficial femoral artery (sfa) with 70% stenosis and was 100 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii a lesion. The target lesion was treated with direct placement of a 6 mm x 120 mm study stent. Following post dilation, residual stenosis was 5%. On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel. On (b)(6) 2020, 793 days post index procedure, the subject was noted to have critical in-stent stenosis on the right leg. On the same day, the subject was hospitalized for further treatment and evaluation. On (b)(6) 2020, 793 days post index procedure, the 90% stenosis in right mid sfa which was 30 mm long with a reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty (pta) (in stent ballooning), resulting in 0% residual stenosis. On (b)(6) 2020, the event was considered recovered/resolved subject was discharged with medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02039 |
| MDR Report Key | 9752064 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2017-06-08 |
| 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 | 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 | 2020-02-25 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0020890480 |
| Device Expiration Date | 2018-12-05 |
| 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 | 2020-02-25 |