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.
[179486038]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[179486039]
It was reported that the device became entrapped on the guidewire and the stent partially deployed. The 99% stenosed target lesion was located in the superficial femoral artery (sfa). Pre-dilation was performed. A 7x120, 130cm eluvia drug-eluting vascular stent system was selected for use. While deploying the stent, the guidewire became stuck in the system and deployment became difficult. Strong force was required to turn the thumbwheel and the stent was placed in the blood vessel for more than 2/3 of its length. The system was then forcibly pulled and the entire length of the stent was placed. The proximal part of the stent was placed in a slightly stretched state, and the procedure was completed. The effect of a kink in the shaft was noted in the iliac bifurcation part during contralateral approach. No patient complications were reported and the patient's status is stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01168 |
| MDR Report Key | 9687572 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-08-29 |
| 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 | 0024502793 |
| 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 |