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 2020-02-20 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180413232]
Device is combination product. Initial reporter phone: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180413233]
(b)(6) clinical study. It was reported that thrombosis occurred. The subject underwent treatment with the 7x80, 130cm study stent on (b)(6) 2019 as part of the regal clinical trial. The target lesion was located in the 100% stenosed proximal, middle and distal left sfa with 200mm referenced length. Reference vessel diameters were 6mm proximally and distally. Pre-dilatation was performed using one balloon and the lesion was crossed through the true lumen. The study stent was implanted. Post-dilatation was performed using one balloon and residual stenosis was 0%. No thrombus was seen in the treated vessel at the end of the procedure. On (b)(6) 2020, a stent thrombosis was observed. Medication was given or regimen was adjusted. The event was assessed as resolved with sequelae with unknown date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01740 |
| MDR Report Key | 9733944 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2018-07-04 |
| Date Added to Maude | 2020-02-20 |
| 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 SCIMED, INC |
| 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 | 2020-02-20 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0022400988 |
| Device Expiration Date | 2019-12-31 |
| 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 | 2020-02-20 |