LVIS
Report
- Report Number
- 2032493-2025-90448
- Event Type
- Malfunction
- Date Received
- August 29, 2025
- Date of Event
- December 17, 2014
- Report Date
- December 22, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- QCA
- UDI-DI
- 00811425029961
- PMA / PMN Number
- P170013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE LOT NUMBER WAS RECEIVED VIA EMAIL. CORRECTIONS. AS A RESULT OF THE UPDATED LOT, CORRECTIONS WERE MADE TO SECTIONS D.4; H.4; H.6 ADDING EVALUATION CODE 3331; H.11: THE ACTUAL DEVICE PRO CODE IN D2 IS NJE AND THE COMMON DEVICE NAME IS INTRACRANIAL NEUROVASCULAR STENT. ADDITIONALLY, CORRECTIONS WERE MADE TO H.6. ADDING HEALTH EFFECT IMPACT CODE 4621, AND EVALUATION CODE 22. H11 - ADDING THE FOLLOWING: BATCH REVIEW: 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
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): POTENTIAL COMPLICATIONS POSSIBLE COMPLICATIONS 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. 24. 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. 25. 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. 26. 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. 28. 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. PROCEDURE/MEDICAL INFORMATION REVIEW: MEDICAL OPERATIVE NOTE REVIEW, A DETAILED MEDICAL REVIEW OF THE OPERATIVE NOTE DATED DECEMBER 17, 2014, WAS PERFORMED. AS MEDICALLY REPORTED IN THE CLINICAL LVIS PAS STUDY, THE PATIENT WAS TREATED FOR A 7MM RIGHT SUPERIOR HYPOPHYSEAL INTERNAL CAROTID ARTERY ANEURYSM WITH AN LVIS (4.5 MMX23 MM) DEVICE. INDEX PROCEDURE DATE WAS DECEMBER 17, 2014, WITH THE EVENT OF INCOMPLETE OPENING OF THE LVIS DEVICE PROXIMAL TO THE TARGET ANEURYSM LOCATION OCCURRING ON DECEMBER 17, 2014 DURING THE PERFORMANCE OF THE PROCEDURE. DATA REVIEWED INDICATES THAT FINAL ANGIOGRAPHIC RUNS DEMONSTRATE SATISFACTORY PACKING OF THE ANEURYSM AND POSITION OF THE INTRALUMINAL SUPPORT DEVICE. THERE IS NO EVIDENCE OF PARENT ARTERY COMPLICATION OR THROMBOEMBOLIC COMPLICATION. ANGIOGRAPHIC RUNS OF THE COMMON FEMORAL ARTERY DEMONSTRATE AN APPROPRIATE LEVEL OF VESSEL ACCESS WITHOUT EVIDENCE OF VESSEL WALL INJURY OR DISSECTION. BASED ON THE REVIEW OF THE DATA AND IN MY PROFESSIONAL OPINION INDICATES THAT THE LVIS INTRALUMINAL STENT DID NOT OPEN IN THE PROXIMAL END OF THE DEVICE OCCURRED AND THE RELATIONSHIP OF THE EVENT TO THE LVIS DEVICE CANNOT BE RULED OUT. DATA REVIEWED DOES NOT PROVIDE THE CIRCUMSTANCES AS TO WHY THE LVIS PROXIMAL STENT DID NOT OPEN. A MEDICAL REVIEW OF THE PROVIDED OPERATIVE NOTE WAS PERFORMED. THE DATA INDICATES THAT THE LVIS INTRALUMINAL STENT DID NOT OPEN IN THE PROXIMAL END OF THE DEVICE OCCURRED AND THEREFORE, THE RELATIONSHIP OF THE EVENT TO THE LVIS DEVICE CANNOT BE RULED OUT. THE REVIEWED DATA DOES NOT PROVIDE THE CIRCUMSTANCES AS TO WHY THE LVIS PROXIMAL STENT DID NOT OPEN. 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.
IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT AN LVIS STENT DID NOT OPEN IN THE PROXIMAL END. AN LVIS INTRALUMINAL SUPPORT DEVICE (4.5 MMX23 MU) WAS DEPLOYED AS SUCH THAT THE DISTAL ASPECT OF THE DEVICE WAS WITHIN THE SUPRA-CLINOID PORTION OF THE INTERNAL CAROTID ARTERY AND THE PROXIMAL ASPECT OF THE STENT WAS WITHIN THE HORIZONTAL CAVERNOUS PORTION. THE DEPLOYMENT WIRE AND HEADWAY 21 MICROCATHETER WERE THEN WITHDRAWN. FINAL ANGIOGRAPHIC RUNS DEMONSTRATE SATISFACTORY PACKING OF THE ANEURYSM AND POSITION OF THE INTRALUMINAL SUPPORT DEVICE. THERE IS NO EVIDENCE OF PARENT ARTERY COMPLICATION OR THROMBOEMBOLIC COMPLICATION. THE HEADWAY 17 AND NEURON CATHETERS WERE WITHDRAWN. ANGIOGRAPHIC RUNS OF THE COMMON FEMORAL ARTERY DEMONSTRATE AN APPROPRIATE LEVEL OF VESSEL ACCESS WITHOUT EVIDENCE OF VESSEL WALL INJURY OR DISSECTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. IT WAS REPORTED THAT NO PART OF THE DEVICE WILL BE RETURNED AS IT REMAINS IMPLANTED. THE PATIENT WAS RETURNED TO THE PERIOPERATIVE CARE UNIT FOR FURTHER OBSERVATION. SUBJECT EXITED STUDY ON (B)(6) 2019.
IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT AN LVIS STENT DID NOT OPEN IN THE PROXIMAL END. AN LVIS INTRALUMINAL SUPPORT DEVICE (4.5 MMX23 MU) WAS DEPLOYED AS SUCH THAT THE DISTAL ASPECT OF THE DEVICE WAS WITHIN THE SUPRA-CLINOID PORTION OF THE INTERNAL CAROTID ARTERY AND THE PROXIMAL ASPECT OF THE STENT WAS WITHIN THE HORIZONTAL CAVERNOUS PORTION. THE DEPLOYMENT WIRE AND HEADWAY 21 MICROCATHETER WERE THEN WITHDRAWN. FINAL ANGIOGRAPHIC RUNS DEMONSTRATE SATISFACTORY PACKING OF THE ANEURYSM AND POSITION OF THE INTRALUMINAL SUPPORT DEVICE. THERE IS NO EVIDENCE OF PARENT ARTERY COMPLICATION OR THROMBOEMBOLIC COMPLICATION. THE HEADWAY 17 AND NEURON CATHETERS WERE WITHDRAWN. ANGIOGRAPHIC RUNS OF THE COMMON FEMORAL ARTERY DEMONSTRATE AN APPROPRIATE LEVEL OF VESSEL ACCESS WITHOUT EVIDENCE OF VESSEL WALL INJURY OR DISSECTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. IT WAS REPORTED THAT NO PART OF THE DEVICE WILL BE RETURNED AS IT REMAINS IMPLANTED. THE PATIENT WAS RETURNED TO THE PERIOPERATIVE CARE UNIT FOR FURTHER OBSERVATION. SUBJECT EXITED STUDY ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2164589 | LVIS | INTRACRANIAL COIL-ASSIST STENT | QCA | MICROVENTION, INC. | 213025-LVIS-C-HDE | 13080845M | 00811425029961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | HEADWAY 21 |