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 2020-03-03 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[181839589]
Patient date of birth: unknown (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[181839590]
It was reported that an intrastent occlusion and stenosis occurred. The patient underwent treatment with the eluvia device on (b)(6) 2019 as part of the (b)(6) clinical trial. The following lesion was treated (left limb): middle superficial femoral artery (sfa) with 250mm length and 100% stenosis. Reference vessel diameters were 4. 4mm and 4. 2mm proximally and distally. Pre-dilatation was performed using one balloon and the lesion was crossed through the true lumen. One eluvia stent (6x40mm) was implanted. Post-dilatation was performed using one balloon and residual stenosis was 10%. No thrombus was seen in the treated vessel at the end of the procedure. On (b)(6) 2019 an intrastent occlusion and left sfa stenosis was observed. The patient was hospitalized and intrastent pta and stenting of the left sfa was performed. The event was reported as resolved on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02379 |
| MDR Report Key | 9779996 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-06-10 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2020-03-03 |
| 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 IRELAND LIMITED |
| 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 | 2020-03-03 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0021832707 |
| Device Expiration Date | 2019-08-19 |
| 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 | 2020-03-03 |