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 2020-02-19 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180390551]
Age at time of event: patient is over 18 years of age. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180390552]
It was reported that the stent was difficult to deploy, and the system got stuck on the guidewire. The lesion was 75% stenosed and located in the mildly calcified superficial femoral artery (sfa). A 7x120x130 eluvia self expanding drug eluting stent was selected for the procedure. During the procedure, the delivery system was delivered contralateral over a non-bsc guidewire and deployment was initiated. The physician felt severe resistance when manipulating the handle during deployment and the pull grip was used to deploy the stent. After the stent was deployed, the non-bsc guidewire could not be removed from the stent system. The guidewire and stent system were removed together. It was noted that there was a slight kink on the proximal side of the delivery system. The procedure was completed successfully using the original stent. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01701 |
| MDR Report Key | 9728468 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-02-19 |
| 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 | 2020-02-19 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0023854120 |
| 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 | 2020-02-19 |