LVIS HDE
Report
- Report Number
- 2032493-2025-90444
- Event Type
- Death
- Date Received
- August 29, 2025
- Date of Event
- March 9, 2025
- Report Date
- October 20, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- QCA
- PMA / PMN Number
- P170013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MICROVENTION IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MICROVENTION, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MICROVENTION HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MICROVENTION, OR ITS EMPLOYEES THAT THE DEVICE, MICROVENTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. A DETAILED MEDICAL REVIEW OF THE (B)(6) 2025, OPERATIVE NOTE, PERFORMED BY MICROVENTION¿S EXPERT PERSONNEL, WAS PERFORMED ON AUGUST 22, 2025: ¿AS REPORTED IN THE LVIS PAS STUDY, THE PATIENT WAS TREATED INITIALLY FOR A BASILAR ARTERY OCCLUSION VIA A MECHANICAL THROMBECTOMY WITH THE USE OF AN LVIS STENT WITH INDEX PROCEDURE DATE OF (B)(6) 2025. ON (B)(6) 2025, FORTY-EIGHT DAYS AFTER PERFORMANCE OF THE INDEX SURGICAL PROCEDURE, THE PATIENT WAS DETERMINED TO BE IN COMA STATUS AFTER BEING FOUND UNRESPONSIVE AT HOME WITH NOTABLE HISTORY FOR RECENT MEDICATION NONCOMPLIANCE (STOPPED ANTIPLATELETS AND ANTICOAGULANTS). DATA REVIEW INDICATES THAT THE PATIENT WAS INTUBATED IN THE FIELD AND BROUGHT TO OSH ED WITH NIHSS 36. OPERATIVE NOTE DATA REVIEWED INDICATES THE PERFORMANCE OF CT SCANNING DETERMINED THE PRESENCE OF AN OCCLUSION OF THE BASILAR ARTERY DOWN TO THE LEVEL OF THE STENT IN THE V4 SEGMENT, CHRONIC R ICA OCCLUSION, AND R P2 OCCLUSION. ACCORDING TO THE OPERATIVE REPORT. THE PATIENT UNDERWENT SUCCESSFUL THROMBECTOMY PROCEDURE WHICH DEMONSTRATED SIGNIFICANTLY IMPROVED FLOW WITHIN THE BASILAR SYSTEM AS WELL AS THE RIGHT HEMISPHERE BEING PROFUSED BY A LARGE PCOM DUE TO A RIGHT INTERNAL CAROTID ARTERY OCCLUSION. ACCORDING TO THE OPERATIVE REPORT PATIENT RECEIVED INTEGRILIN TO MAINTAIN PATENCY WITHIN THE STENT AND WAS ALSO GIVE HEPARIN. DATA REVIEWED INDICATES THAT THE PATIENT'S POST-PROCEDURE EXAM IMPROVED SLIGHTLY (REACTIVE R PUPIL, COUGH), BUT MRI SHOWED EXTENSIVE INFARCTS IN POSTERIOR FOSSA AND BILATERAL ANTERIOR AND POSTERIOR CIRCULATION. THE PATIENT'S CONDITION WAS REPORTED AS POOR PROGNOSIS STATUS. BASED ON THE REVIEW OF THE DATA TO INCLUDE PATIENT HISTORY OF MEDICINAL NON-COMPLIANCE (PATIENT STOPPED ANTIPLATELETS AND ANTICOAGULANTS) AND IN MY PROFESSIONAL OPINION, THE RELATIONSHIP OF THE EVENT TO THE DEVICE HAS BEEN DETERMINED TO BE UNKNOWN, AS THE EXACT CIRCUMSTANCES AS TO WHY THE STENT OCCLUSION OCCURRED HAVE NOT BEEN DETERMINED AND PROVIDED.¿ INVESTIGATION FINDINGS: 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. WITHOUT IMAGING, THE INVESTIGATION CANNOT FURTHER VERIFY IF THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EVALUATE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE THE PRESENCE OF ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AN ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION WAS PERFORMED. COMPLAINT SYSTEM REVIEW: A SEARCH OF THE COMPLAINT HANDLING SYSTEM COULD NOT BE PERFORMED TO DETERMINE IF OTHER SIMILAR COMPLAINTS EXIST FOR THIS BATCH NUMBER, BECAUSE THE BATCH NUMBER WAS NOT PROVIDED FOR THE PRODUCT ON THIS COMPLAINT FILE. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): ADVERSE EVENTS POSSIBLE ADVERSE EVENTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: HEMATOMA AT THE PUNCTURE SITE, PERFORATION OR DISSECTION OF THE VESSEL(S), INTRAVASCULAR SPASM, HEMORRHAGING, RUPTURE OR PERFORATION OF ANEURYSM, COIL HERNIATION, DEVICE MIGRATION, NEUROLOGIC INSUFFICIENCIES INCLUDING STROKE AND DEATH, ISCHEMIA, VASCULAR OCCLUSION, VESSEL STENOSIS, INCOMPLETE ANEURYSM OCCLUSION, PSEUDOANEURYSM FORMATION, DISTAL EMBOLIZATION, HEADACHE, INFECTION. REACTION TO CONTRAST AGENTS INCLUDING SEVERE ALLERGIC REACTIONS AND RENAL FAILURE WARNINGS SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING ACCESS OR REMOVAL, THE INTRODUCER/GUIDE CATHETER/MICROCATHETER AND LVIS DEVICE SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE DURING DELIVERY OR RETRIEVAL OF THE LVIS DEVICE CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE DEVICE AND DELIVERY COMPONENTS. IT IS IMPERATIVE TO USE THE LVIS DEVICE WITH COMPATIBLE MICROCATHETERS. IF REPEATED FRICTION IS ENCOUNTERED DURING LVIS DEVICE DELIVERY, VERIFY MICROCATHETER IS NOT KINKED OR IN EXTREMELY TORTUOUS ANATOMY. CONFIRM THAT THE MICROCATHETER DOES NOT OVALIZE. CONFIRM THAT THERE IS ADEQUATE STERILE FLUSH SOLUTION. DO NOT REPOSITION THE LVIS DEVICE IN THE PARENT VESSEL WITHOUT FULLY RETRIEVING THE DEVICE. THE LVIS DEVICE MUST BE RETRIEVED INTO THE MICROCATHETER AND RE-DEPLOYED AT THE DESIRED TARGET LOCATION OR REMOVED COMPLETELY FROM THE PATIENT. DIRECTIONS FOR USE 15. ADVANCE THE DELIVERY WIRE TO TRANSFER THE LVIS DEVICE FROM WITHIN THE INTRODUCER INTO THE MICROCATHETER. WARNING: DO NOT TORQUE THE DELIVERY WIRE WHILE ADVANCING OR RETRACTING THE LVIS DEVICE. A TORQUE DEVICE SHOULD NOT BE USED. 16. CONTINUE ADVANCING THE DELIVERY WIRE INTO THE MICROCATHETER UNTIL THE PROXIMAL TIP OF THE DELIVERY WIRE ENTERS THE INTRODUCER. LOOSEN THE RHV LOCKING RING, REMOVE THE INTRODUCER, AND SET IT ASIDE. WARNING: DO NOT APPLY UNDUE FORCE. IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING LVIS DEVICE DELIVERY OR MANIPULATION, WITHDRAW THE UNIT AND SELECT A NEW LVIS DEVICE. 18. POSITION THE LVIS DEVICE FOR DEPLOYMENT BY ALIGNING THE LVIS IMPLANT DISTAL RADIOPAQUE END MARKERS APPROXIMATELY 7 MM PAST THE ANEURYSM NECK. NOTE: A PROPER PUSH/PULL TECHNIQUE, ENCOMPASSING SUFFICIENT DELIVERY WIRE PUSH FORCE, IN ADDITION TO AN OPPOSING MICROCATHETER WITHDRAWAL FORCE, WILL FACILITATE PROPERLY DEPLOYING THE LVIS DEVICE TO ACHIEVE FULL EXPANSION AND GOOD VESSEL APPOSITION. NOTE: SLOWLY ADVANCING THE LVIS DEVICE WHILE ADJUSTING THE MICROCATHETER POSITION WILL ENSURE ACCURATE DEPLOYMENT. MAINTAIN SIMULTANEOUS CONTROL OF THE LVIS DEVICE AND MICROCATHETER IN ORDER TO POSITION AND EXPAND THE DEVICE AT THE PROPER LOCATION. CAUTION: USING A RAPID MICROCATHETER WITHDRAWAL TECHNIQUE TO DEPLOY THE LVIS DEVICE IS NOT RECOMMENDED AND MAY RESULT IN DEVICE ELONGATION. 19. IF LVIS DEVICE POSITIONING IS NOT SATISFACTORY, THE LVIS DEVICE MAY BE RECAPTURED AND REPOSITIONED IF IT IS NOT FULLY DEPLOYED. THE LVIS DEVICE MAY BE RECAPTURED UNTIL THE POINT WHERE THE PROXIMAL END OF THE LVIS DEVICE MARKERS IS ALIGNED 3 MM PROXIMALLY WITH THE MICROCATHETER DISTAL MARKER BAND (APPROXIMATELY 80% DEPLOYED). CAUTION: IF RESISTANCE IS FELT WHILE RECAPTURING THE LVIS DEVICE, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE MICROCATHETER SLIGHTLY TO UNSHEATH THE LVIS DEVICE (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE LVIS DEVICE. CAUTION: THE LVIS DEVICE MUST NOT BE RE-DEPLOYED MORE THAN THREE TIMES. NOTE: THE LVIS DEVICE DELIVERY WIRE SHOULD NOT BE UTILIZED AS A GUIDEWIRE. DO NOT TORQUE THE LVIS DEVICE. A TORQUE DEVICE SHOULD NOT BE USED. 20. IF LVIS DEVICE POSITIONING IS SATISFACTORY, CAREFULLY RETRACT THE MICROCATHETER AND ADVANCE THE DELIVERY WIRE TOGETHER, TO ALLOW THE LVIS DEVICE TO DEPLOY ACROSS THE NECK OF THE ANEURYSM. ENSURE THE DEVICE PROXIMAL RADIOPAQUE END MARKERS ARE APPROXIMATELY 7 MM PROXIMAL TO THE ANEURYSM NECK TO ENSURE AN ADEQUATE LANDING ZONE. THE LVIS DEVICE WILL EXPAND AND TOTAL LENGTH MAY FORESHORTEN UP TO 60% FROM ITS UNDEPLOYED LENGTH AS IT EXITS THE MICROCATHETER. ENSURE MICROCATHETER IS RETRACTED AND CLEAR FROM THE PROXIMAL FLARED ENDS. NOTE: VISUALIZE AND REFER TO THE IMPLANT RADIOPAQUE END MARKERS TO MAINTAIN ADEQUATE IMPLANT LENGTH, APPROXIMATELY 7 MM ON EACH SIDE OF THE ANEURYSM NECK OR TARGET LOCATION TO ENSURE APPROPRIATE NECK COVERAGE. WARNING: DO NOT DETACH THE LVIS DEVICE IF IT IS NOT PROPERLY POSITIONED IN THE PARENT VESSEL. OBSERVE THE DELIVERY WIRE DISTAL TIP TO ASSURE IT REMAINS WITHIN THE DESIRED LOCATION OF THE PARENT VESSEL. 21. PRIOR TO REMOVING THE DELIVERY WIRE AND IF NECESSARY, CAREFULLY POSITION THE MICROCATHETER DISTAL TO THE LVIS DEVICE TO MAINTAIN ACCESS THROUGH THE LVIS DEVICE. REMOVE AND DISCARD THE DELIVERY WIRE. WARNING: THE LVIS DEVICE DELIVERY WIRE SHOULD NOT BE UTILIZED AS A GUIDEWIRE. DO NOT TORQUE THE LVIS DEVICE. A TORQUE DEVICE SHOULD NOT BE USED. 23. USE THE GUIDEWIRE AND MICROCATHETER TO ACCESS THE ANEURYSM THROUGH THE LVIS DEVICE CELLS. WARNING: OBSERVE LVIS DEVICE MARKER POSITION DURING PLACEMENT OF THE MICROCATHETER INTO THE ANEURYSM TO ENSURE THAT THE LVIS DEVICE DOES NOT MIGRATE OR DISLODGE FROM ITS DEPLOYED POSITION. 24. AFTER THE MICROCATHETER IS POSITIONED WITHIN THE ANEURYSM, DETACHABLE COILS MAY BE DELIVERED INTO THE ANEURYSM ACCORDING TO CONVENTIONAL METHODS. WARNING: OBSERVE LVIS DEVICE MARKER POSITION DURING THE COILING PROCEDURE TO ENSURE THAT THE DEVICE DOES NOT MIGRATE FROM ITS DEPLOYED POSITION. 25. AFTER PLACING THE LAST COIL, VERIFY THAT THE LVIS DEVICE HAS REMAINED PATENT AND PROPERLY POSITIONED. ADVANCE A GUIDEWIRE TO THE MICROCATHETER TIP AND CAREFULLY REMOVE THE MICROCATHETER THROUGH THE LVIS DEVICE CELLS. NOTE: A MICROCATHETER MAY BE POSITIONED INTO THE ANEURYSM SAC PRIOR TO DELIVERY OF THE LVIS DEVICE. THE MICROCATHETER WILL BE SUPPORTED BY THE LVIS DEVICE DURING DELIVERY OF EMBOLIC COILING. AFTER COMPLETING THE COILING, THE MICROCATHETER SHOULD BE CAREFULLY REMOVED TO AVOID DISLODGING THE LVIS DEVICE. 27. CAUTION: CAREFULLY WATCH THE LVIS DEVICE DISTAL AND PROXIMAL MARKERS WHEN PASSING THROUGH THE DEPLOYED LVIS DEVICE WITH EMBOLIC COILING MICROCATHETERS TO AVOID DISPLACING THE LVIS DEVICE.
A SUPPLEMENTAL IS BEING PROVIDED OF THE REPORTED STENT THROMBOSIS. ADJUDICATION INDICATED RELATED TO THE STUDY DEVICE.
AS REPORTED THROUGH THE LVIS PAS STUDY: EVENT TERM: COMA. EVENT #: 2 EVENT START DATE: (B)(6) 2025. POST OPERATIVE DAYS: 47. EVENT DESCRIPTION: COMA LEADING TO DEATH. SUBJECT WITH NF-1 AND PRIOR INTRACRANIAL VERTEBRAL STENT (LVIS PLACED (B)(6) 2025) PRESENTED ON (B)(6) IN COMA AFTER BEING FOUND UNRESPONSIVE AT HOME (LAST KNOWN NORMAL 0830). HISTORY NOTABLE FOR RECENT MEDICATION NONCOMPLIANCE (STOPPED ANTIPLATELETS AND ANTICOAGULANTS). INTUBATED IN THE FIELD AND BROUGHT TO OSH ED WITH NIHSS 36. ON TRANSFER TO TREATING HOSPITAL, EXAM SHOWED PINPOINT PUPILS, POSITIVE COUGH AND OCRS, AND EXTENSOR POSTURING. CTA SHOWED OCCLUSION OF THE LEFT V4 STENT EXTENDING INTO THE PROXIMAL BASILAR ARTERY, CHRONIC R ICA OCCLUSION, AND R P2 OCCLUSION. NO TNK GIVEN DUE TO EXTENDED LKN; TRANSFERRED FOR EVT. UNDERWENT SUCCESSFUL THROMBECTOMY WITH TICI 2C FLOW. POST-PROCEDURE EXAM IMPROVED SLIGHTLY (REACTIVE R PUPIL, COUGH), BUT MRI SHOWED EXTENSIVE INFARCTS IN POSTERIOR FOSSA AND BILATERAL ANTERIOR AND POSTERIOR CIRCULATION. GIVEN POOR PROGNOSIS, FAMILY OPTED FOR COMFORT CARE. SUBJECT WAS TERMINALLY EXTUBATED AND DIED AT 11:12 ON (B)(6). IMMEDIATE CAUSE OF DEATH: BRAIN COMPRESSION. UNDERLYING CAUSE LEADING TO ABOVE: ACUTE ISCHEMIC STROKE. UNDERLYING CAUSE LEADING TO ABOVE: VERTEBRAL ARTERY STENT OCCLUSION. UNDERLYING CAUSE LEADING TO ABOVE: MEDICATION NON- COMPLIANCE. SITE ASSESSED RELATIONSHIP: UNKNOWN RELATIONSHIP. AE OUTCOME: DEATH.
ADDITIONAL INFORMATION: THE REPORTED STENT THROMBOSIS IS ADJUDICATED BY CEC STUDY DEVICE-RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2879303 | LVIS HDE | INTRACRANIAL COIL-ASSIST STENT | QCA | MICROVENTION, INC. | 214035-LVIS-C-HDE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Death| R |