LVIS HDE
Report
- Report Number
- 2032493-2024-00806
- Event Type
- Malfunction
- Date Received
- November 7, 2024
- Date of Event
- June 28, 2018
- Report Date
- November 25, 2024
- Manufacturer
- MICROVENTION, INC.
- Product Code
- QCA
- UDI-DI
- 00812636022239
- PMA / PMN Number
- H130005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: THE CORRECT PRODUCT CODE IN SECTION D SHOULD BE NJE, HOWEVER, THE CURRENT SYSTEM DOES NOT HAVE NJE AS AN OPTION TO BE CHOSEN. QCA WAS CHOSEN AS IT IS THE CLOSEST ALTERNATIVE. ITEMS RETURNED: N/A. VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WERE NOT PROVIDED FOR THIS INVESTIGATION. 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 DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: THERE ARE NO SIMILAR COMPLAINTS BASED ON THE COMPLAINT CATEGORY REGARDING THIS BATCH NUMBER FROM THE LAST TWO YEARS RECORDED IN THE COMPLAINT SYSTEM AT THE TIME OF THIS INVESTIGATION. IFU REVIEW: 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 OR OCCLUSION BALLOONS. 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. PRECAUTIONS EXERCISE CAUTION WHEN CROSSING THE DEPLOYED/DETACHED LVIS DEVICE WITH ADJUNCTIVE DEVICES SUCH AS GUIDEWIRES, CATHETERS, MICROCATHETERS OR BALLOON CATHETERS TO AVOID DISRUPTING THE DEVICE GEOMETRY AND DEVICE PLACEMENT. 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. [FIGURE 6] 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 75% DEPLOYED). [FIGURE 7] 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 55% FROM ITS UNDEPLOYED LENGTH (REFER TO TABLE 1) 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. [FIGURE 8] 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. THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO 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.
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 EVALUATION. PROCEDURAL OR MEDICAL IMAGING WAS NOT PROVIDED. THE ALLEGED PRODUCT ISSUE/EVENT AS DESCRIBED COULD NOT BE CONFIRMED.
AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: WHEN THE LVIS BLUE STENT WAS DEPLOYED, THE PROXIMAL LUMEN LANDED IN THE HORIZONTAL SEGMENT OF THE CAVERNOUS LEFT ICA. THE STENT DID NOT APPEAR COMPLETELY EXPANDED ALONG THE ANTERIOR GENU OF THE CAVERNOUS ICA. THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF THE STENT. PATIENT DID NOT REQUIRE A TREATMENT/INTERVENTION AS A RESULT OF THE EVENT AND WAS DISCHARGED THE NEXT DAY. SITE REPORTED 2 EVENTS FOR THE PATIENT. EVENT #1: WEAKNESS/NUMBNESS PATIENT COMPLAINED OF RIGHT ARM WEAKNESS AND NUMBNESS (EIGHT DAYS POST-OP), MODERATE SEVERITY, TREATED WITH MEDICATION. NEURO-EVALUATION NOTED MRS OF 2 (SEVEN DAYS POST-OP). RESOLVED WITHOUT SEQUELAE WITH NEURO-EVALUATION NOTED MRS OF 1 (6 MONTHS POST OP). EVENT #2: HEADACHE PATIENT COMPLAINED OF INTERMITTENT, NONSPECIFIC HEADACHES - MILD TO MODERATE SEVERITY (1334 DAYS POST-OP). NO TREATMENT WAS REQUIRED, WITH OUTCOME OF ONGOING. PATIENT EXITED STUDY AFTER COMPLETING THE 5 YEAR FOLLOW UP. THE WEAKNESS/NUMBNESS AND HEADACHE WERE DETERMINED TO BE NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED: THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF THE STENT. TO ADDRESS THE INCOMPLETE OPENING, A BALLOON CATHETER WAS PREPARED IN THE STANDARD FASHION. THE MICROCATHETER WAS REMOVED, AND THE BALLOON CATHETER WAS ADVANCED OVER A STANDARD MICROWIRE THROUGH THE GUIDE CATHETER AND INTO THE STENT. THE BALLOON WAS GENTLY INFLATED ALONG THE LENGTH OF THE STENT. REPEAT CATHETER ANGIOGRAPHY SHOWED IMPROVED EXPANSION OF THE STENT, WITH APPOSITION OF THE STENT TO THE INTERNAL CAROTID ARTERY ALONG ITS LENGTH. THE BALLOON CATHETER WAS REMOVED. CASE WAS COMPLETED VIA POST-EMBOLIZATION ANGIOGRAPHY IMMEDIATELY AFTER BALLOON REMOVAL, IMAGES DEMONSTRATED COMPLETE OBLITERATION OF THE ANEURYSM SAC. POST PROCEDURE THERE WERE NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSPORTED TO THE POST-PROCEDURE MONITORING AREA IN STABLE CONDITION.
AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: WHEN THE LVIS BLUE STENT WAS DEPLOYED, THE PROXIMAL LUMEN LANDED IN THE HORIZONTAL SEGMENT OF THE CAVERNOUS LEFT ICA. THE STENT DID NOT APPEAR COMPLETELY EXPANDED ALONG THE ANTERIOR GENU OF THE CAVERNOUS ICA. THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF THE STENT. PATIENT DID NOT REQUIRE A TREATMENT/INTERVENTION AS A RESULT OF THE EVENT AND WAS DISCHARGED THE NEXT DAY. SITE REPORTED 2 EVENTS FOR THE PATIENT. EVENT #1: WEAKNESS/NUMBNESS PATIENT COMPLAINED OF RIGHT ARM WEAKNESS AND NUMBNESS (EIGHT DAYS POST-OP), MODERATE SEVERITY, TREATED WITH MEDICATION. NEURO-EVALUATION NOTED MRS OF 2 (SEVEN DAYS POST-OP). RESOLVED WITHOUT SEQUELAE WITH NEURO-EVALUATION NOTED MRS OF 1 (6 MONTHS POST OP). EVENT #2: HEADACHE PATIENT COMPLAINED OF INTERMITTENT, NONSPECIFIC HEADACHES - MILD TO MODERATE SEVERITY (1334 DAYS POST-OP). NO TREATMENT WAS REQUIRED, WITH OUTCOME OF ONGOING. THE WEAKNESS/NUMBNESS AND HEADACHE WERE DETERMINED TO BE NOT RELATED TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2133363 | LVIS HDE | INTRACRANIAL COIL-ASSIST STENT | QCA | MICROVENTION, INC. | 214035-LVIS-D-HDE | 180110514 | 00812636022239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | HEADWAY 21. |