Brand Name | ORSIRO MISSION (US) 4.0/13 |
Type of Device | CORONARY DRUG-ELUTING STENT |
Manufacturer (Section D) |
BIOTRONIK AG, BUELACH, SWITZERLAND |
ackerstrasse 6 |
buelach CH-81 80 |
CH CH-8180 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 18057843 |
MDR Text Key | 327259351 |
Report Number | 1028232-2023-05615 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
UDI-Device Identifier | 07640130455924 |
UDI-Public | (01)07640130455924(17)2505 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | P170030 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/02/2023 |
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 Model Number | 453936 |
Device Catalogue Number | SEE MODEL NO. |
Device Lot Number | 04233871 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/19/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/09/2023
|
Initial Date FDA Received | 11/02/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/25/2023 |
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 |
Patient Outcome(s) |
Hospitalization;
|