Brand Name | XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
Type of Device | DRUG ELUTING CORONARY 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 | 12790908 |
MDR Text Key | 281591609 |
Report Number | 2024168-2021-10225 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
UDI-Device Identifier | 08717648233319 |
UDI-Public | 08717648233319 |
Combination Product (y/n) | Y |
Reporter Country Code | JA |
PMA/PMN Number | P110019 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/10/2021 |
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 | 09/14/2023 |
Device Model Number | 1804325-15 |
Device Catalogue Number | 1804325-15 |
Device Lot Number | 0091041 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/28/2021 |
Initial Date FDA Received | 11/10/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/15/2020 |
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 | (MERIT MEDICAL) INDEFLATOR |