Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
Type of Device | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
1 edwards way |
irvine CA 92614 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES |
1 edwards way |
|
irvine CA 92614 |
|
Manufacturer Contact |
renee
van dorne
|
1 edwards way |
irvine, CA 92614
|
9492506385
|
|
MDR Report Key | 15658748 |
MDR Text Key | 305879569 |
Report Number | 2015691-2022-08782 |
Device Sequence Number | 1 |
Product Code |
NPT
|
UDI-Device Identifier | 00690103193961 |
UDI-Public | (01)00690103193961(17)240623(10)64415041 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P140031 |
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,Followup |
Report Date |
12/22/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/23/2024 |
Device Model Number | 9600LDS29A |
Device Catalogue Number | 9600LDS29A |
Device Lot Number | 64415041 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/03/2022 |
Initial Date FDA Received | 10/24/2022 |
Supplement Dates Manufacturer Received | 12/22/2022
|
Supplement Dates FDA Received | 12/22/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/27/2022 |
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 |