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 2020-02-26 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[181424867]
Initial reporter facility name: (b)(6), liver disease department.
Patient Sequence No: 1, Text Type: N, H10
[181424868]
It was reported that the stent elongated during deployment. A 6x120x130 eluvia drug-eluting vascular stent system was selected for a percutaneous transluminal angioplasty (pta) procedure in the 100% stenosed lesion located in the moderately tortuous and calcified left superficial femoral artery (sfa). During the procedure, the device was advanced into the patient over a non-bsc guidewire. The physician had difficulties deploying the stent and it was noted the stent was stretched. An additional eluvia stent was placed inside the stent due to the stretched stent. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02126 |
| MDR Report Key | 9758781 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-07-11 |
| 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 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 | 2020-02-26 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0024198339 |
| 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 |