Brand Name | FLEXNAV DELIVERY SYSTEM |
Type of Device | Aortic valve, prosthesis, percutaneously delivered |
Manufacturer (Section D) |
ABBOTT MEDICAL |
5050 nathan lane n |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ABBOTT MEDICAL REG#3007113487 |
177 county road b east |
|
st. paul MN 55117 1789 |
|
Manufacturer Contact |
karen
krouse
|
5050 nathan lane n |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 18877696 |
MDR Text Key | 337567112 |
Report Number | 2135147-2024-01073 |
Device Sequence Number | 1 |
Product Code |
NPT
|
UDI-Device Identifier | 05415067031389 |
UDI-Public | 05415067031389 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P190023 |
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 |
03/11/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/11/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | FNAV-DS-LG |
Device Lot Number | 9138320 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/15/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/12/2023 |
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 |
Treatment | LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 9138320] |
Patient Age | 80 YR |
Patient Sex | Female |