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 2020-03-09 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[182794728]
This is a combination device. Age at time of event: patient was (b)(6) years old at the time of study enrollment. Initial reporter address 1: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182794729]
(b)(6) clinical trial. It was reported that stent thrombosis occurred. The subject was enrolled in the (b)(6) study on (b)(6) 2020 and the index procedure was performed on the same day. The target lesion was located in left distal superficial femoral artery (sfa) with 100% stenosis and was 80mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5mm and was classified as tasc ii b lesion. Target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent. Following post dilation, the residual stenosis was 0%. On (b)(6) 2020 the subject was discharged on aspirin. On (b)(6) 2020, 10 days post index procedure, subject was noted with unknown symptoms of claudication/stenosis in left leg. Angiography revealed thrombosis in left distal sfa. No action was taken to treat the event. At the time of reporting, the event was considered ongoing. No additional information is available at this point of time and the site has been queried for source documents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02731 |
| MDR Report Key | 9805074 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-09-14 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0022768645 |
| 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. Other | 2020-03-09 |