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 2020-03-20 for PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 ICV1210 manufactured by Livanova Canada Corp..
[184371972]
Device disposition presently unknown.
Patient Sequence No: 1, Text Type: N, H10
[184371973]
The manufacturer was notified of a serious adverse event involving a patient with a perceval pvs25 sutureless aortic heart valve. The information was as follows. On (b)(6) 2019 the patient passed away as a result of mesenteric ischemia, secondary to failed perceval bioprosthesis and iatrogenic root rupture. No further information was received including the date of implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004478276-2020-00141 |
| MDR Report Key | 9863003 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-04-15 |
| Date Added to Maude | 2020-03-20 |
| 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, 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 VALVE |
| Product Code | LWR |
| Date Received | 2020-03-20 |
| Model Number | PVS25 |
| Catalog Number | ICV1210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA CANADA CORP. |
| Manufacturer Address | 5005 N FRASER WAY BURNABY, BC V5J 5M1 CA V5J 5M1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-20 |