Brand Name | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE |
Type of Device | PROSTHESIS, MITRAL VALVE, 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 | 16308293 |
MDR Text Key | 308895313 |
Report Number | 2015691-2023-10611 |
Device Sequence Number | 1 |
Product Code |
NPU
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P130009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/22/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9300TFX26 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/12/2023 |
Initial Date FDA Received | 02/06/2023 |
Supplement Dates Manufacturer Received | 02/24/2023
|
Supplement Dates FDA Received | 03/22/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|