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 2020-03-13 for ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM 24620 manufactured by Boston Scientific Corporation.
[183371863]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183371864]
(b)(6) trial it was reported that stent occlusion occurred. Subject enrolled in the study on (b)(6) 2016 and index procedure was performed that day. The target lesions were in the left proximal superficial femoral artery and the left mid-superficial femoral artery. A 6mmx150mmx130cm drug eluting study stent and a 6mmx100mmx75cm drug eluting study stent were implanted. On (b)(6) 2020, 3 years, 26 days post index procedure, left superficial femoral in-stent occlusion was noted. On (b)(6) 2020, subject was hospitalized and an interventional procedure was performed. On (b)(6) 2020 the subject was discharged and the event was considered resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03161 |
| MDR Report Key | 9831062 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2020-03-13 |
| 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 | ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-13 |
| Model Number | 24620 |
| Catalog Number | 24620 |
| Lot Number | 0018779191 |
| Device Expiration Date | 2016-12-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-13 |