LVIS
Report
- Report Number
- 2032493-2022-00360
- Event Type
- Malfunction
- Date Received
- September 3, 2022
- Date of Event
- July 27, 2022
- Report Date
- August 15, 2022
- Manufacturer
- MICROVENTION, INC
- Product Code
- QCA
- UDI-DI
- 00812636020013
- PMA / PMN Number
- P170013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THEREFORE, THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRM. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION INC WILL ISSUE A SUPPLEMENTAL REPORT.
THE REPORTED COMPLAINT IS NONVERIFIABLE AS THE STENT WAS NOT RETURNED AND THE PHYSICIAN DID NOT PROVIDE ANY CORROBORATING IMAGES. PER THE IFU, THE DEVICE SHOULD HAVE BEEN PREPPED BY PARTIALLY DEPLOYING IN SALINE PRIOR TO INSERTION INTO THE MICROCATHETER. THE INVESTIGATION FOUND NO DAMAGE OR ANOMALY TO THE PUSHER OR INTRODUCER THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.
IT WAS REPORTED THAT DURING TREATMENT USING A LVIS DEVICE, NO STENT WAS OBSERVED UNDER DSA IMAGING. IT WAS REPORTED THAT THE DEVICE WAS USED WITHOUT INSPECTION PRIOR TO USE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417622 | LVIS | INTRACRANIAL COIL-ASSISR STENT | QCA | MICROVENTION, INC | 212525-CAS-D-CN | 210622584 | 00812636020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female |