Brand Name | LVIS JR. |
Type of Device | INTRALUMINAL STENT |
Manufacturer (Section D) |
MICROVENTION, INC. |
35 enterprise |
aliso viejo CA 92656 |
|
Manufacturer Contact |
terrence
callahan
|
35 enterprise |
aliso viejo, CA 92656
|
7142478000
|
|
MDR Report Key | 17174287 |
MDR Text Key | 317940467 |
Report Number | 2032493-2023-00805 |
Device Sequence Number | 1 |
Product Code |
QCA
|
UDI-Device Identifier | 00842429103302 |
UDI-Public | (01)00842429103302(11)210422(17)240331(10)21042258G |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P170013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/05/2023 |
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 Expiration Date | 03/31/2024 |
Device Model Number | 172014-CASJ-C-CN |
Device Lot Number | 21042258G |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/16/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/05/2023
|
Initial Date FDA Received | 06/21/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/22/2021 |
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 Age | 53 YR |
Patient Sex | Female |
Patient Weight | 59 KG |
|
|