Brand Name | EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM |
Type of Device | HEART-VALVE, NON-ALLOGRAFT TISSUE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela, costa rica 01897 -405 |
CS 01897-4050 |
|
MDR Report Key | 9910560 |
MDR Text Key | 186575354 |
Report Number | 3008452825-2020-00173 |
Device Sequence Number | 1 |
Product Code |
LWR
|
UDI-Device Identifier | 05414734055604 |
UDI-Public | 05414734055604 |
Combination Product (y/n) | N |
PMA/PMN Number | P040021 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
05/01/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/01/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/25/2023 |
Device Model Number | E100-31M-00 |
Device Catalogue Number | E100-31M-00 |
Device Lot Number | 6949000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/01/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/14/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 78 YR |
Patient Weight | 77 |
|
|