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 PERCEVAL SUTURELESS AORTIC HEART VALVE TBD manufactured by Livanova Canada Corp.
[184387602]
The device was returned to the manufacturer and it was received on (b)(6) 2020. A full device investigation is currently undergoing and the results will be provided upon completion of the testing. Device evaluation ongoing.
Patient Sequence No: 1, Text Type: N, H10
[184387603]
The manufacturer was informed about an explant of a perceval valve that occurred on (b)(6) 2020, after 2 years of implant. No further information is presently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004478276-2020-00140 |
| MDR Report Key | 9855643 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| 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 | MS FRANCESCA CROVATO |
| Manufacturer Street | 5005 NORTH FRASER WAY |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5J 5M1 |
| Manufacturer Country | CA |
| Manufacturer Postal | V5J 5M1 |
| Manufacturer G1 | LIVANOVA CANADA CORP |
| Manufacturer Street | 5005 NORTH FRASER WAY |
| Manufacturer City | BURNABY, BRITISH COLUMBIA 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 VALVES |
| Product Code | LWR |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-04 |
| Model Number | TBD |
| Catalog Number | TBD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-19 |