Brand Name | EDWARDS INSPIRIS RESILIA AORTIC VALVE |
Type of Device | HEART-VALVE, NON-ALLOGRAFT TISSUE |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
1 edwards way |
irvine CA 92614 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES |
1 edwards way |
|
irvine CA 92614 |
|
Manufacturer Contact |
saurav
singh
|
1 edwards way |
irvine, CA 92614
|
|
MDR Report Key | 18944657 |
MDR Text Key | 338187026 |
Report Number | 2015691-2024-02153 |
Device Sequence Number | 1 |
Product Code |
LWR
|
UDI-Device Identifier | 00690103194975 |
UDI-Public | (01)00690103194975(17)210605 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150048 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/20/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/20/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/05/2021 |
Device Model Number | 11500A21 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/26/2024 |
Date Device Manufactured | 06/06/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
Life Threatening;
|
Patient Age | 62 YR |
Patient Sex | Female |