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 2019-11-29 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 ICV1209 manufactured by Livanova Canada Corp..
Report Number | 3004478276-2019-00322 |
MDR Report Key | 9391999 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-09-06 |
Date Mfgr Received | 2019-10-30 |
Device Manufacturer Date | 2019-01-31 |
Date Added to Maude | 2019-11-29 |
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 | FRANCESCA CROVATO |
Manufacturer Street | 5005 N FRASER WAY |
Manufacturer City | BURNABY, BC V5J 5M1 |
Manufacturer Country | CA |
Manufacturer Postal | V5J 5M1 |
Manufacturer G1 | LIVANOVA CANADA CORP |
Manufacturer Street | 5005 NORTH FRASER WAY |
Manufacturer City | BURNABY, BC V5J 5M1 |
Manufacturer Country | CA |
Manufacturer Postal Code | V5J 5M1 |
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 | 2019-11-29 |
Model Number | PVS25 |
Catalog Number | ICV1209 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | LIVANOVA CANADA CORP. |
Manufacturer Address | 5005 NORTH FRASER WAY BURNABY, BC V5J 5M1 CA V5J 5M1 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-11-29 |