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 2020-02-07 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[179471266]
It was reported that stent damage occurred. The 25. 6mmx5. 2mm, ulcerative plaque stenosis was located in the left vertebral artery. A 6. 0-22 carotid wallstent was selected for use. However, it was noticed that the stent was exposed and the stent struts were lifted. The physician attempted to reconstrain the stent outside the patient's body. The stent could not be reconstrained and the stent struts remained lifted. No patient complications were reported and the patient was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01081 |
| MDR Report Key | 9681959 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-08-29 |
| Date Added to Maude | 2020-02-07 |
| 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 | CAROTID WALLSTENT |
| Generic Name | STENT, CAROTID |
| Product Code | NIM |
| Date Received | 2020-02-07 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0024345951 |
| 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 | 2020-02-07 |