MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS23 ICV1209 manufactured by Livanova Canada Corp.
| Report Number | 1718850-2020-01048 |
| MDR Report Key | 9886230 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-27 |
| Date Facility Aware | 2020-02-27 |
| Report Date | 2020-02-27 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCEVAL SUTURELESS AORTIC HEART VALVE |
| Generic Name | TISSUE HEART VALVE |
| Product Code | LWR |
| Date Received | 2020-03-26 |
| Model Number | PVS23 |
| Catalog Number | ICV1209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA CANADA CORP |
| Manufacturer Address | 5005 NORTH FRASER WAY BURNABY, BRITISH COLUMBIA V5J 5M1 CA V5J 5M1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |