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 2020-02-26 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[181423141]
Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[181423142]
(b)(6) clinical study. It was reported that stent thrombosis occurred. The subject underwent treatment with two study devices on (b)(6) 2019 as part of the eminent clinical trial. The target lesion was located in right mid distal superficial femoral artery (sfa) with 100% stenosis. The lesion was 150 mm long with a proximal and distal reference vessel diameter of 6 mm and was classified as a tasc ii c lesion. The target lesion was treated with pre-dilatation and placement of the 6 mm x 120 mm and 6 mm x 80 mm stents. Following post dilation, residual stenosis was 10%. On (b)(6) 2019, the subject was discharged on aspirin and clopidogrel. On (b)(6) 2020, the subject presented for the 6-month follow-up visit. The patient was noted with a walking distance limitation of 90 m with calf claudication in the right leg. On the same day, duplex ultrasound revealed occlusion of right sfa and occlusion of the downstream stent. The subject was diagnosed with 'paod grade iib on the right due to early occlusion of the stent of the right sfa' and thrombectomy was recommended on the later date. On (b)(6) 2020 the 100% stenosis in right mid to distal sfa which was 150 mm long with a reference vessel diameter of 6 mm was treated with thrombectomy followed by drug-coated balloon dilatation and stenting, resulting in 20% final stenosis. On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02076 |
| MDR Report Key | 9757165 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0023718466 |
| 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 | 2020-02-26 |