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 2019-05-30 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[146614011]
It was reported that the patient experienced a stroke. The patient presented for a transcatheter aortic valve replacement (tavr) procedure. A sentinel embolic protection device was deployed in normal fashion with both filters deployed. The procedure was completed. The patient was fine immediately after the tavr procedure. The day after the tavr procedure the patient experienced stroke like symptoms with difficulty speaking and bilateral weakness. Within in 2 days all symptoms where gone. It is unclear to the depth of the stroke. The cause of the stroke is unknown. Per the physician the patient is fine and doing well. The patient has made a full recovery and was discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05588 |
| MDR Report Key | 8656320 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-05-03 |
| Device Manufacturer Date | 2019-03-11 |
| Date Added to Maude | 2019-05-30 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| 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 | 2019-05-30 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 19C12H09 |
| 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 | 2019-05-30 |