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 2020-03-19 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[184144238]
It was reported that a cerebral vascular accident, ocular injury, cerebral hemorrhage, and death occurred. A sentinel cerebral protection system was selected for use during a mitral valve-in-valve procedure. Heparin was given. The sentinel cerebral protection system was inserted and deployed the patients right brachial artery and left common corradit artery. The sentinel was deployed within two (2) minutes without issue. The physicians then implanted a 20mm non boston scientific valve. Once the valve was in place and they were happy with the result, the sentinel device was retrieved with ease. The patient was doing well and moving all four (4) extremities while waking up from anesthesia. It was then noticed that she had blown one of her pupils. An immediate computed tomography was performed and revealed a minor brain bleed and evidence of an embolic stroke. The patient passed away later that day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02403 |
| MDR Report Key | 9855966 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-19 |
| 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 | CLARET MEDICAL, INC. |
| Manufacturer Street | 1745 COPPERHILL PARKWAY SUITE 1 |
| 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 | 2020-03-19 |
| 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. Death | 2020-03-19 |