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 2020-03-19 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[184164806]
Patient identifier: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184164807]
It was reported that stent thrombosis occurred. The subject was enrolled into the eminent study on (b)(6) 2017 and the index procedure was performed on the same day. The target lesion was located in the right mid to distal superficial femoral artery (sfa) and had 100% occlusion, a proximal reference vessel diameter of 5. 5 mm, a distal reference vessel diameter of 5. 5 mm, and a length of 70 mm. The lesion was classified as a tasc ii b lesion. The target lesion was treated with pre dilatation and placement of a 6 x 100 mm study stent. Post dilatation was performed with 5 % residual stenosis. On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel. On (b)(6) 2018, the subject started experiencing pain in the right leg. On (b)(6) 2018, the subject presented due to worsening pain in the right leg and an inability to walk. It was noted that the day prior, the subject had clamminess, sweating, and dizziness. Duplex imaging of the arteries of the right leg revealed, low flow in the common femoral artery, filiform open lumen proximal in the sfa over a length of 2 cm, and further complete occlusion of the sfa. Irrigation of the leg via the posterior fibular artery (pfa), reperfusion proximal in the popliteal artery (a little before the origin of the suralis artery), and otherwise normal accessible popliteal artery with very low flow was observed. At the level of the ankle, very low flow is demonstrated in the arteries. On the same day, the right sfa was treated with ultrasound guided thrombolysis with 50% residual stenosis. On (b)(6) 2018, the mid-grade thrombosis stenosis in mid stent and high-grade stenosis in the ostial pfa was treated with balloon dilatation using a non-bsc 5 x 80 mm balloon with 10% residual stenosis. On the same day, event was considered recovered and resolved. On (b)(6) 2018, subject was discharged on aspirin and clopidogrel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03602 |
| MDR Report Key | 9856436 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2016-08-03 |
| Date Added to Maude | 2020-03-19 |
| 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 | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| 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 | 2020-03-19 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0019635396 |
| Device Expiration Date | 2018-01-31 |
| 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 | 2020-03-19 |