LVIS D
Report
- Report Number
- 2032493-2025-90240
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- May 18, 2025
- Report Date
- August 28, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- QCA
- UDI-DI
- 00842429115893
- PMA / PMN Number
- H130005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ONE RADIOGRAPHIC IMAGE AND ONE RADIOGRAPHIC VIDEO WERE PROVIDED FOR REVIEW. THEY SHOW THE RADIOPAQUE TIP OF THE STENT PUSHER BROKEN OFF, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE; HOWEVER, THEY DO NOT EXPLAIN WHY THE PUSHER GOT STUCK AND ULTIMATELY FRACTURED. WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT CODE IS SECTION D SHOULD BE NJE, HOWEVER, THAT IS NOT AN AVAILABLE OPTION IN THE SYSTEM. THUS, THE PRODUCT CODE QCA WAS SELECTED AS IT IS A SIMILAR CODE.
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 IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. THE INVESTIGATION IS ONGOING AND UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE PRODUCT CODE IS SECTION D SHOULD BE NJE, HOWEVER, THAT IS NOT AN AVAILABLE OPTION IN THE SYSTEM. THUS, THE PRODUCT CODE QCA WAS SELECTED AS IT IS A SIMILAR CODE.
THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE. THE PRODUCT CODE IS SECTION D SHOULD BE NJE, HOWEVER, THAT IS NOT AN AVAILABLE OPTION IN THE SYSTEM. THUS, THE PRODUCT CODE QCA WAS SELECTED AS IT IS A SIMILAR CODE.
ONE RADIOGRAPHIC IMAGE AND ONE RADIOGRAPHIC VIDEO WERE PROVIDED FOR REVIEW. THEY SHOW THE RADIOPAQUE TIP OF THE STENT PUSHER BROKEN OFF; HOWEVER, THEY DO NOT EXPLAIN WHY THE PUSHER GOT STUCK AND ULTIMATELY FRACTURED. THE INVESTIGATION OF THE RETURNED DEVICE FOUND THE PUSHER BROKEN AND CURLED AT THE DISTAL END, WHICH IS CONSISTENT WITH THE CUSTOMER-PROVIDED IMAGES AND THE ALLEGED PRODUCT ISSUE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES THAT EXCEEDED THE PUSHER'S YIELD AND TENSILE STRENGTHS. THE STENT AND MICROCATHETER WERE NOT RETURNED, SO THE INVESTIGATION COULD NOT DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE PRODUCT CODE IS SECTION D SHOULD BE NJE, HOWEVER, THAT IS NOT AN AVAILABLE OPTION IN THE SYSTEM. THUS, THE PRODUCT CODE QCA WAS SELECTED AS IT IS A SIMILAR CODE.
NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. HOWEVER, IMAGING WAS PROVIDED.
AS REPORTED: PERCUTANEOUS PUNCTURE OF INTRACRANIAL ANEURYSM, STENT-ASSISTED EMBOLIZATION. THE PATIENT HAS AN ANEURYSM AT THE MIDDLE BIFURCATION OF THE RIGHT BRAIN. THE STENT-ASSISTED EMBOLIZATION TREATMENT WAS PLANNED, AND THE PROCEDURE CHOSE LVIS STENT-ASSISTED COIL EMBOLIZATION. THE STENT WAS COMPLETELY RELEASED THROUGH THE MICROCATHETER. WHEN REMOVING THE PUSHER OF THE STENT, THE PHYSICIAN FELT THAT THE PUSHER WAS STUCK. THE PHYSICIAN PUSHED FORWARD BUT COULDN'T REMOVE IT. THE PHYSICIAN REPEATEDLY PUSHED AND PULLED, MAKING MANY ATTEMPTS. FINALLY, THE PUSHER WAS REMOVED, AND THE GUIDE WIRE AT THE HEAD END OF THE STENT WAS BROKEN INSIDE THE PATIENT. THE PHYSICIAN TRIED TO PULL IT OUT WITH THE PUSHER, BUT STILL COULDN'T PULL IT OUT. THE PHYSICIAN TRIED TO PULL IT OUT WITH A MICRO GUIDEWIRE, BUT STILL COULDN'T PULL IT OUT. FINALLY, IT WAS HUNG ON A STENT, AND THE PHYSICIAN HAD NO CHOICE BUT TO END THE PROCEDURE. PATIENT IS FINE.
NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.
NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318702 | LVIS D | INTRACRANIAL COIL-ASSIST STENT | QCA | MICROVENTION, INC. | 213517-CAS-D | 0000696173 | 00842429115893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | HEADWAY 21 MICROCATHETER. |