LVIS JR.
Report
- Report Number
- 2032493-2024-00476
- Event Type
- Injury
- Date Received
- June 18, 2024
- Date of Event
- June 1, 2024
- Report Date
- July 18, 2024
- Manufacturer
- MICROVENTION INC.
- Product Code
- QCA
- UDI-DI
- 00816777028624
- PMA / PMN Number
- P170013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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 IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. HOWEVER, IMAGING WAS PROVIDED. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
IN SECTION D2, THE ORIGINAL COMMON DEVICE NAME INTRACRANIAL COIL-ASSIST STENT IS NOT CORRECT. IT WAS CORRECTED TO STENT. IN SECTION G5, THE PMA NUMBER P170013 WAS ADDED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT IS DOCUMENTED IN B5. TWO RADIOGRAPHIC IMAGES ARE PROVIDED. THEY ARE NOT LABELED AS TO TIME OR DATE. FLUOROSCOPIC IMAGE 1: SINGLE SHOT UNSUBTRACTED RADIOGRAPH, AP, NO CONTRAST. A FULLY OPEN AND DETACHED WEB IS SEEN. BY THE COMPLAINT, IT IS IN A BASILAR TIP ANEURYSM. AN LVIS JR. SPANS FROM THE RIGHT P2 TO THE DISTAL ¼ OF THE BASILAR ARTERY. IT IS OPEN, EXCEPT FOR THE SEGMENT AT THE JUNCTION OF THE HORIZONTAL P1 AND THE VERTICAL DISTAL BASILAR, WHERE IT IS EITHER NOT OPEN, OR TWISTED. THE COMPLAINT SAYS THAT THE PROXIMAL TINES ARE NOT FULLY OPENED, BUT I CANNOT EVALUATE THAT SINCE NO CONTRAST WAS GIVEN ON THE IMAGE. FLUOROSCOPIC IMAGE 2: SAME AS THE FIRST IMAGE, BUT LATERAL PROJECTION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT DEFINITIVELY DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE 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. 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 JR. DEVICE SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE DURING DELIVERY OR RETRIEVAL OF THE LVIS JR. DEVICE CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE DEVICE AND DELIVERY COMPONENTS. IT IS IMPERATIVE TO USE THE LVIS JR. DEVICE WITH COMPATIBLE MICROCATHETERS. IF REPEATED FRICTION IS ENCOUNTERED DURING LVIS JR. 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 JR. DEVICE IN THE PARENT VESSEL WITHOUT FULLY RETRIEVING THE DEVICE. THE LVIS JR. 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 JR. 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 JR. DEVICE FROM WITHIN THE INTRODUCER INTO THE MICROCATHETER. WARNING: DO NOT TORQUE THE DELIVERY WIRE WHILE ADVANCING OR RETRACTING THE LVIS JR. 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 JR. DEVICE DELIVERY OR MANIPULATION, WITHDRAW THE UNIT AND SELECT A NEW LVIS JR. DEVICE. 18. POSITION THE LVIS JR. DEVICE FOR DEPLOYMENT BY ALIGNING THE LVIS JR. IMPLANT DISTAL 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 JR. DEVICE TO ACHIEVE FULL EXPANSION AND GOOD VESSEL APPOSITION. NOTE: SLOWLY ADVANCING THE LVIS JR. DEVICE WHILE ADJUSTING THE MICROCATHETER POSITION WILL ENSURE ACCURATE DEPLOYMENT. MAINTAIN SIMULTANEOUS CONTROL OF THE LVIS JR. 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 JR. DEVICE IS NOT RECOMMENDED AND MAY RESULT IN DEVICE ELONGATION. 19. IF LVIS JR. DEVICE POSITIONING IS NOT SATISFACTORY, THE LVIS JR. DEVICE MAY BE RECAPTURED AND REPOSITIONED IF IT IS NOT FULLY DEPLOYED. THE LVIS JR. DEVICE MAY BE RECAPTURED UNTIL THE POINT WHERE THE PROXIMAL END OF THE LVIS JR. 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 JR. DEVICE, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE MICROCATHETER SLIGHTLY TO UNSHEATHE THE LVIS JR. DEVICE (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE LVIS JR. DEVICE. CAUTION: THE LVIS JR. DEVICE MUST NOT BE RE-DEPLOYED MORE THAN THREE TIMES. NOTE: THE LVIS JR. DEVICE DELIVERY WIRE SHOULD NOT BE UTILIZED AS A GUIDEWIRE. DO NOT TORQUE THE LVIS JR. DEVICE. A TORQUE DEVICE SHOULD NOT BE USED. 20. IF LVIS JR. DEVICE POSITIONING IS SATISFACTORY, CAREFULLY RETRACT THE MICROCATHETER AND ADVANCE THE DELIVERY WIRE TOGETHER, TO ALLOW THE LVIS JR. 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 JR. DEVICE WILL EXPAND AND TOTAL LENGTH MAY FORESHORTEN UP TO 35% FROM ITS UNDEPLOYED LENGTH (REFER TO TABLES 1 AND 2) 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 JR. 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 JR. DEVICE TO MAINTAIN ACCESS THROUGH THE LVIS JR. DEVICE. REMOVE AND DISCARD THE DELIVERY WIRE. WARNING: THE LVIS JR. DELIVERY WIRE SHOULD NOT BE USED AS A GUIDEWIRE. DO NOT TORQUE THE LVIS JR. DEVICE. A TORQUE DEVICE SHOULD NOT BE USED. 24. USE THE GUIDEWIRE AND MICROCATHETER TO ACCESS THE ANEURYSM THROUGH THE LVIS JR. DEVICE CELLS. WARNING: OBSERVE LVIS JR. DEVICE MARKER POSITION DURING PLACEMENT OF THE MICROCATHETER INTO THE ANEURYSM TO ENSURE THAT THE LVIS JR. 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 JR. 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 JR. DEVICE HAS REMAINED PATENT AND PROPERLY POSITIONED. ADVANCE A GUIDEWIRE TO THE MICROCATHETER TIP AND CAREFULLY REMOVE THE MICROCATHETER THROUGH THE LVIS JR. DEVICE CELLS. NOTE: A MICROCATHETER MAY BE POSITIONED INTO THE ANEURYSM SAC PRIOR TO DELIVERY OF THE LVIS JR. DEVICE. THE MICROCATHETER WILL BE SUPPORTED BY THE LVIS JR. DEVICE DURING DELIVERY OF EMBOLIC COILING. AFTER COMPLETING THE COILING, THE MICROCATHETER SHOULD BE CAREFULLY REMOVED TO AVOID DISLODGING THE LVIS JR. DEVICE. 28. CAUTION: CAREFULLY WATCH THE LVIS JR. DEVICE DISTAL AND PROXIMAL MARKERS WHEN PASSING THROUGH THE DEPLOYED LVIS JR. DEVICE WITH EMBOLIC COILING MICROCATHETERS TO AVOID DISPLACING THE LVIS JR. DEVICE.
IT WAS REPORTED THAT DURING A RUPTURED BASILAR TIP ANEURYSM TREATMENT USING A WEB FOR AN ICU PATIENT WITH EVD, THE WEB WAS DEPLOYED INTO ANEURYSM, BUT THE OPERATORS FELT THAT THE WEB WAS HERNIATING INTO RIGHT P1 CAUSING DECREASED FLOW. A STENT WAS PLACED FROM THE RIGHT P1 INTO THE BASILAR, AND A CATHETER WAS ACCESSED TO THE RIGHT P1. THE STENT WAS DEPLOYED THROUGH IT AND WAS OPPOSING WELL DISTALLY AT THE RIGHT P1 AND BASILAR BIFURCATION. HOWEVER, WHEN THE CATHETER REACHED THE VERY END OF THE STENT AT THE PROXIMAL TINES, THE STENT¿S PROXIMAL FLARED ENDS DID NOT OPEN FULLY. THE MIDDLE OF THE STENT APPEARED TWISTED. ATTEMPTS TO OPEN THE STENT BY USING A GUIDEWIRE MASSAGE AND BALLOON ANGIOPLASTY HAD A MINIMAL OPENING AT BEST. HOWEVER, AT THE RIGHT P1, THE PATIENT POST STENT DEPLOYMENT IMAGING SHOWS WEB DEVICE REMAINS IN ANEURYSM. THE PATIENT WAS THEN ADMINISTERED INTEGRILLIN AND ADDITIONAL ANTICOAGULATION TO END THE PROCEDURE. THE PATIENT REMAINS IN THE HOSPITAL ON EVD AND TRANSFERRED TO ICU FOR CLOSE MONITORING. THE PATIENT DOES HAVE SEVERAL INFRACTS THAT BELIEVES RESULTED FROM THE SUB-OPTIMAL STENT OPENING. THE PATIENT'S CURRENT STATUS AND PLANS FOR ADDITIONAL TREATMENT IS UNKNOWN.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT REMAINS HOSPITALIZED WITH SOME POSTERIOR STROKES OCCURRING PREVIOUSLY. THE PATIENT IS RECOVERING SLOWLY AND REMAINS UNDER MEDICAL CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780972 | LVIS JR. | STENT | QCA | MICROVENTION INC. | 172516-CASJ-C-CA | 0000154901 | 00816777028624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |