Brand Name | OMNILINK ELITE PERIPHERAL STENT SYSTEM |
Type of Device | PERIPHERAL STENT DELIVERY SYSTEM |
Manufacturer (Section D) |
ABBOTT VASCULAR |
26531 ynez rd. |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR, REG # 3005718570 (P099) |
cashel road |
|
clonmel tipperary |
EI
|
|
Manufacturer Contact |
lindsey
bell
|
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 19126872 |
MDR Text Key | 340446386 |
Report Number | 2024168-2024-04781 |
Device Sequence Number | 1 |
Product Code |
NIO
|
UDI-Device Identifier | 08717648179334 |
UDI-Public | (01)08717648179334(17)250731(10)2022241 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P110043 |
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 |
04/17/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/17/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1012625-29 |
Device Lot Number | 2022241 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/26/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/22/2022 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 61 YR |
Patient Sex | Female |