Brand Name | PERCEVAL SUTURELESS AORTIC HEART VALVE |
Type of Device | TISSUE HEART VALVE |
Manufacturer (Section D) |
LIVANOVA CANADA CORP. |
5005 north fraser way |
burnaby, bc V5J 5 M1 |
CA V5J 5M1 |
|
Manufacturer (Section G) |
LIVANOVA CANADA CORP |
5005 north fraser way |
|
burnaby, bc V5J 5 M1 |
CA
V5J 5M1
|
|
Manufacturer Contact |
francesca
crovato
|
5005 n fraser way |
burnaby, bc V5J 5-M1
|
CA
V5J 5M1
|
|
MDR Report Key | 9433925 |
MDR Text Key | 171971304 |
Report Number | 3004478276-2019-00328 |
Device Sequence Number | 1 |
Product Code |
LWR
|
UDI-Device Identifier | 00896208000429 |
UDI-Public | (01)00896208000429(240)ICV1209(17)220127 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P150011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/06/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/06/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/27/2022 |
Device Model Number | PVS23 |
Device Catalogue Number | ICV1209 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/02/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/08/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/27/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
Patient Weight | 65 |