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 2020-02-10 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[179484765]
Date of event: no date provided, used the first date in the month of the aware date.
Patient Sequence No: 1, Text Type: N, H10
[179484766]
It was reported that partial deployment occurred and the device became stuck on the guidewire. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery (sfa). Contralateral approach was performed and a 0. 014" non-bsc guidewire was advanced. The distal part was dilated with a drug coated balloon. During deployment to place the 6x120, 130cm eluvia drug-eluting vascular stent system from the mid to the proximal, thumbwheel spinning/idling occurred, and it became difficult to deploy the stent midway. The stent was able to be placed while pulling the outer. While trying to pull out the eluvia shaft from the sheath, the guidewire became stuck and could not be removed. The stent system was removed with the guidewire. The physician noted that the shaft might have been bent near the thumbwheel. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01161 |
| MDR Report Key | 9687477 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-07-24 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0024255192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-10 |