MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-29 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[185663679]
Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185663680]
It was reported that inadvertent deployment occurred. Vascular access was gained via contralateral approach. The 90% stenosed target lesion was located in the severely calcified and moderately tortuous right superficial femoral artery (sfa). The lesion was predilated to 5mmx6cm. A 6fr guide sheath was used. A 6x1200x130 eluvia drug-eluting vascular stent system and a non-bsc guidewire were selected for use. The device was unable to cross the lesion. The stent was not deployed and the shaft was removed after trial and error; however the edge of stent was protruding from the shaft. There were no defects on the stent or shaft after removal. The procedure was completed with a non-bsc stent. The patient was good and there were no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04040 |
| MDR Report Key | 9896141 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-03-29 |
| 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 | 2020-03-29 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0023588952 |
| 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 | 2020-03-29 |