MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-07 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[173968520]
It was reported that a stroke occurred. A sentinel cerebral protection system was placed followed by balloon aortic valvuloplasty and implantation of a 27mm lotus edge valve. The next day, the patient had slurred speech, somnolence and left facial drooping. An embolic stroke was detected in the right temporal lobe. Dual antiplatelet therapy was continued and the patient was monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-16281 |
| MDR Report Key | 9558193 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-07 |
| 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 | CLARET MEDICAL, INC. |
| Manufacturer Street | 1745 COPPERHILL PARKWAY |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENTINEL CEREBRAL PROTECTION SYSTEM (US) |
| Generic Name | EMBOLIC PROTECTION DEVICE |
| Product Code | PUM |
| Date Received | 2020-01-07 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL, INC. |
| Manufacturer Address | 1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-07 |