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 2020-02-20 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180412986]
It was reported that the stent fractured and the patient experienced recurrent claudication. A 6x120 130cm eluvia drug-eluting vascular stent system was implanted in the superficial femoral artery (sfa) during a procedure on (b)(6) 2017. The patient returned to the lab with recurrent claudication in (b)(6) 2020. Upon angiographic follow-up, the eluvia stent was noted to be fractured in multiple locations and appeared to almost be disintegrated. Revascularization was performed and endovascular repair of the stent was completed successfully. The patient's status post procedure was excellent and no further claudication was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01783 |
| MDR Report Key | 9733180 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2016-09-22 |
| Date Added to Maude | 2020-02-20 |
| 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 | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| 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 | 2020-02-20 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0019873608 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-20 |