R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
Report
- Report Number
- 9681834-2023-00037
- Event Type
- Malfunction
- Date Received
- February 23, 2023
- Date of Event
- January 30, 2023
- Report Date
- February 23, 2023
- Manufacturer
- TERUMO MEDICAL CORPORATION
- Product Code
- NIP
- UDI-DI
- 04987350727787
- PMA / PMN Number
- P140002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. INITIAL REPORTER OCCUPATION: INTERVENTIONAL CARDIOLOGIST. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER FROM OTHER FACILITIES. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).
VISUAL INSPECTION OF THE ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS. AT THE DISTAL END OF HANDLE, IT HAD BEEN KINKED AND BENT AT THE ANTI-KINKING SLEEVE AND THE SHAFT IN THE VICINITY OF ANTI-KINKING SLEEVE, AND PART OF THE SHAFT HAD BEEN DAMAGED. THE SLIDING PART HAD BEEN MOVED TO THE HAND SIDE BY APPROXIMATELY 160 MILLIMETERS (MM), AND THE STENT HAD BEEN DEPLOYED TO THE ENTIRE LENGTH. THE INNER SHAFT HAD BEEN KINKED AT APPROXIMATELY 45MM FROM THE DISTAL END. THE CATHETER HAD BEEN WAVED, AND COMPRESSIVE FORCE WAS APPLIED. MAGNIFYING INSPECTION IN THE VICINITY OF DISTAL END OF THE HANDLE OF ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS. AT THE DAMAGED SECTION OF SHAFT, THE SHAFT HAD BEEN TORN IN A TORN SHAPE. THE REINFORCEMENT HAD BEEN KINKED AND THE RELEASE WIRE HAD BEEN BENT. THE DISTAL END OF ANTI-KINKING SLEEVE HAD BEEN BENT. MAGNIFYING INSPECTION OF THE SLIDING PART (WHERE THE STENT WAS MOUNTED) OF ACTUAL SAMPLE FOUND THAT IT HAD BEEN DENTED INTERMITTENTLY. IN ADDITION, IT HAD BEEN CRUSHED AT APPROXIMATELY 35MM AND 110MM FROM THE DISTAL END OF SLIDING PART. ELECTRON MICROSCOPIC INSPECTION OF THE SLIDING PART (WHERE THE STENT WAS MOUNTED) OF ACTUAL SAMPLE FOUND MULTIPLE ABRASIONS. SINCE MOST OF THE ABRASIONS OCCURRED TOWARD THE DISTAL DIRECTION, IT WAS INFERRED THAT SOME HARD OBJECT (E.G., CALCIFIED LESION) CAME INTO CONTACT WITH THE SURFACE OF SLIDING PART WHEN THE SLIDING PART WAS ABOUT TO MOVE TO THE HAND SIDE. THE SLIDING PART WAS REMOVED TO OBSERVE. THE OUTER DIAMETER OF SLIDING PART (WHERE THE STENT WAS MOUNTED) WAS MEASURED. IT MET THE FACTORY'S SPECIFICATIONS AND NO ANOMALY WAS FOUND. MAGNIFYING INSPECTION OF THE OF ACTUAL SAMPLE AT THE FIXED PART OF SLIDING PART AND RELEASE WIRE DID NOT FIND ANY ANOMALY SUCH AS DETACHMENT OF THE FIXED PART. MAGNIFYING INSPECTION OF THE SHAFT OF ACTUAL SAMPLE DID NOT FIND ANY DEFORMATION SUCH AS A CRUSH OR KINK. X-RAY FLUOROSCOPIC INSPECTION OF THE INSIDE OF HANDLE OF THE ACTUAL SAMPLE CONFIRMED THAT THE RELEASE WIRE HAD BEEN WOUND IN A CIRCLE ON THE THUMBWHEEL, AND NO ANOMALY WAS FOUND IN THE WINDING SHAPE. X-RAY FLUOROSCOPIC INSPECTION OF THE INSIDE OF ACTUAL SAMPLE CONFIRMED THAT THE RELEASE WIRE WAS NOT FRACTURED. THE RELEASE WIRE HAD BEEN DEFLECTED INSIDE THE SHAFT. THEREFORE, IT WAS INFERRED THAT RESISTANCE HAD OCCURRED WHEN THE RELEASE WIRE WAS WOUND. MAGNIFYING INSPECTION OF THE INNER SHAFT (WHERE THE STENT WAS MOUNTED) OF ACTUAL SAMPLE DID NOT FIND ANY ANOMALY SUCH AS A SCRATCH THAT COULD LEAD TO THE KINK AT THE KINKED SECTION AT APPROXIMATELY 45MM FROM THE DISTAL END. NO DEFORMATION SUCH AS A KINK OR CRUSH WAS FOUND IN OTHER SECTIONS. MAGNIFYING INSPECTION OF THE INNER SHAFT AT THE CRUSHED SECTION ON THE SLIDING PART (WHERE THE STENT WAS MOUNTED) OF ACTUAL SAMPLE FOUND THAT IT HAD BEEN CRUSHED IN THE SAME WAY. THEREFORE, IT WAS INFERRED THAT AFTER THE SLIDING PART MOVED TO THE HAND SIDE AND THE STENT WAS DEPLOYED OVER ITS ENTIRE LENGTH, COMPRESSIVE FORCE WAS APPLIED, AND THE INVOLVED SECTION WAS CRUSHED. REGARDING THIS CASE, IT WAS INFERRED THAT THE SLIDING PART (WHERE THE STENT WAS MOUNTED) OF ACTUAL SAMPLE WAS TRAPPED BY SOME HARD OBJECT (CALCIFICATION). WHEN THE THUMBHOLE WAS CLICKED WHILE THE CATHETER WAS INSUFFICIENTLY HELD, THE SLIDING PART WAS HINDERED FROM MOVING TOWARD THE HAND SIDE, CAUSING THE SHAFT TO WAVE. THEN, THE DISTAL END OF ANTI-KINKING SLEEVE WAS DAMAGED. BASED ON THE ABOVE, THE FOLLOWING SIMULATION TEST WAS PERFORMED. IN THE SIMULATED LOWER LIMB BLOOD VESSEL MODEL, A CONTRALATERAL APPROACH WAS TAKEN WITH FACTORY-RETAINED DESTINATION 6FR 45CM, AND THE DISTAL END OF DESTINATION WAS POSITIONED AT THE ILIAC. THEN, ALONG THE 0.014-INCH GLIDEWIRE ADVANTAGE, MISAGO WITH THE INVOLVED PRODUCT CODE WAS INSERTED INTO SFA, AND THE SLIDING PART (STENT MOUNT PART) OF MISAGO WAS TRAPPED OVER THE SIMULATED TUBE WITH FORCEPS. ONLY THE HANDLE WAS HELD WITHOUT HOLDING MISAGO CATHETER, AND STARTED CLICKING THE THUMBWHEEL. AT 7 CLICKS, THE CLICK BECAME HEAVY, CAUSING WAVES IN THE SHAFT LOCATED OUTSIDE THE BODY. WHEN ONLY THE HANDLE IS HELD, IF THE MOVEMENT OF THE SLIDING PART TO THE HAND SIDE IS HINDERED DUE TO THE INFLUENCE OF A STENOSIS LESION, FORCE IN THE COMPRESSION DIRECTION IS APPLIED TO THE ENTIRE SHAFT, AND A WAVE OF THE SHAFT MAY OCCUR. THEREFORE, DURING STENT DEPLOYMENT, IT IS RECOMMENDED TO HOLD THE CATHETER TO REDUCE SHAFT WAVINESS. AFTER THAT, AS THE CLICKING CONTINUED, THE HEAVINESS INCREASED, AND WAVING OF THE SHAFT OUTSIDE THE BODY PROGRESSED. AT THE SAME TIME, THE SLIDING PART INSIDE THE BODY ALSO WAVED. AT 20 CLICKS, THE STENT BEGAN TO DEPLOY. AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) BELOW, THE STENT USUALLY BEGINS TO DEPLOY AFTER 10 - 15 CLICKS WHEN FORCE IS NOT APPLIED TO THE SLIDING PART OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE. ONLY AS A GUIDE, THE STENT BEGINS TO RELEASE AFTER 5 - 10 CLICKS OF THE THUMBWHEEL FOR STENT LENGTHS OF 100MM OR LESS, AND 10 - 15 CLICKS FOR STENT LENGTHS OF 120MM OR GREATER. BY CONTINUING TO CLICK, THE STENT DEPLOYED APPROXIMATELY 10MM AT 30 CLICKS, AND DEPLOYED APPROXIMATELY 30MM AT 60 CLICKS. CLICKING WAS THEN CONTINUED, BUT THE STENT COULD NOT BE DEPLOYED FURTHER. AT 70 CLICKS, SINCE THE WAVINESS OF SHAFT OUTSIDE THE BODY PROGRESSED, THE SHAFT AT HAND SIDE IN THE VICINITY OF HANDLE WAS WOUND AROUND. IN ADDITION, THE REINFORCEMENT KINKED AT THE DISTAL END OF HANDLE, AND TEARING FORCE WAS APPLIED TO THE SHAFT. AT 80 CLICKS, THE SHAFT WAS TORN AT THE DISTAL END OF ANTI-KINKING SLEEVE, CAUSING A TEAR. DUE TO TEARING, THE KINKED REINFORCEMENT AND THE BENT RELEASE WIRE WERE EXPOSED. IN ADDITION, THE DISTAL END OF ANTI-KINKING SLEEVE WAS BENT. THE CONDITION OF SIMULATED MISAGO WAS LIKELY TO BE SIMILAR TO THE CONDITION OF ACTUAL SAMPLE. HOWEVER, ALTHOUGH THE REPORTED ISSUE STATED THAT "MISAGO STENT WAS DEPLOYED IN THE SFA SUCCESSFULLY" AT THE TIME OF EVENT, THE ENTIRE LENGTH OF STENT COULD NOT BE DEPLOYED IN THE SIMULATION TEST. IT WAS INFERRED THAT THE DEPLOYMENT CONDITION OF STENT CHANGED DUE TO THE BALANCE BETWEEN THE FORCE THAT TRAPS THE SLIDING PART IN THE CALCIFIED LESION AND THE FORCE THAT PULLS THE SLIDING PART TOWARD THE HAND SIDE WITH THE RELEASE WIRE. AS OF FEBRUARY 16, 2023, THE ACTUAL SAMPLE HAS NOT BEEN RECEIVED BY ASHITAKA FACTORY YET. THIS IS THE MDR PRELIMINARY REPORT BASED ON THE REVIEW OF RELEVANT RECORDS AS FOLLOWS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT AND THE SIMULATION TEST RESULT, IT WAS LIKELY THAT SINCE THE SLIDING PART (STENT MOUNT PART) OF ACTUAL SAMPLE WAS TRAPPED BY SOME HARD OBJECT (E.G., CALCIFIED LESION), THE RELEASE WIRE PREVENTED THE SLIDING PART FROM BEING PULLED TOWARD THE HAND SIDE, APPLYING COMPRESSIVE FORCE TO THE SHAFT AND CAUSING WAVINESS. IN ADDITION, DUE TO INSUFFICIENT HOLDING OF THE CATHETER DURING DEPLOYMENT, WAVINESS OF THE CATHETER PROGRESSED EVERY TIME THE CLICK WAS CONTINUED, AND FINALLY THE REINFORCEMENT KINKED AT THE DISTAL END OF ANTI-KINKING SLEEVE, AND TEARING FORCE WAS APPLIED TO THE SHAFT, RESULTING IN DAMAGE. HOWEVER, SINCE THE STENT COULD NOT BE FULLY DEPLOYED IN THE SIMULATION TEST, AND THE STENT WAS SUCCESSFULLY DEPLOYED IN THE EVENT, THE CAUSE OF OCCURRENCE COULD NOT BE IDENTIFIED. IN ADDITION, IT WAS INFERRED THAT THE CRUSH OF SLIDING PART AND THE KINK OF INNER SHAFT WERE CAUSED BY THE APPLICATION OF COMPRESSIVE FORCE AND BENDING FORCE AFTER RELEASE. THEREFORE, IT WAS PRESUMED THAT THERE WAS NO CAUSAL RELATIONSHIP WITH THIS CASE. IF WAVINESS OF THE SHAFT OCCURS, CONTINUE TO ROTATE THE THUMBWHEEL TO DEPLOY THE STENT, ELIMINATE THE FRICTIONAL RESISTANCE BETWEEN THE SLIDING PART AND THE STENT, RELEASE THE FORCE COMPRESSING THE SHAFT, AND ELIMINATE WAVINESS. HOWEVER, DUE TO INSUFFICIENT HOLDING OF THE CATHETER, WAVINESS OF THE SHAFT MAY PROGRESS, THE SHAFT MAY FRACTURE ON THE HAND SIDE AS IN THE INVOLVED EVENT, AND THE REINFORCEMENT AND THE RELEASE WIRE MAY BE EXPOSED. THEREFORE, FOR FUTURE USE, PLEASE KEEP IN MIND THE FOLLOWING DIRECTIONS FOR USE AND PRECAUTION DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU): "[DIRECTIONS FOR USE 3-6]: TO MAINTAIN THE POSITION OF THE DELIVERY CATHETER WHILE ROTATING THE THUMBWHEEL, GRIP THE DELIVERY CATHETER BY HAND AT THE OPERATOR SIDE (PROXIMAL) OF THE INTERMEDIATE SHAFT AND DO NOT MOVE THE DELIVERY CATHETER AT THE OPERATOR SIDE OF THE INTERMEDIATE SHAFT." "[DIRECTIONS FOR USE 4-3 PRECAUTIONS]: DEPLOY THE STENT COMPLETELY, EVEN IF THE DELIVERY CATHETER BENDS AND CORRUGATES. (REMOVAL OF THE DELIVERY CATHETER PRIOR TO FULL DEPLOYMENT OF THE STENT COULD CAUSE THE STENT TO DEPLOY IN AN UNEXPECTED SITE.) IN ADDITION, IF THERE IS HEAVINESS WHEN CLICKING OR IF THE WAVINESS OF SHAFT DOES NOT DISAPPEAR AT ALL, WE WOULD LIKE YOU TO INVESTIGATE THE CAUSE UNDER X-RAY FLUOROSCOPY AND TAKE CAREFUL MEASURES (E.G., REMOVE THE SYSTEM)." ASHITAKA FACTORY MANUFACTURING PROCESS HAS BEEN MAKING EFFORTS IN MAINTAINING THE QUALITY OF THE PRODUCT BY PERFORMING FOLLOWING INSPECTIONS. AFTER STENT PROCESSING, 100% INSPECTION OF THE STENT STRUT BY AN IMAGING DEVICE IS PERFORMED TO ASSURE THAT THE STENT STRUT IS NOT DEFORMED OR FRACTURED. AFTER THE STENT PROCESSING, THE WIDTH AND THICKNESS OF THE STENT STRUT ARE INSPECTED ON 100% BASIS BY AN IMAGING DEVICE. AFTER THE STENT IS MOUNTED ON THE DELIVERY CATHETER, 100% VISUAL INSPECTION IS PERFORMED TO ASSURE THAT THERE IS NO ANOMALY SUCH AS OVERLAP, DEFORMATION OR FRACTURE OF THE STENT STRUT. IN ADDITION, IT IS CONFIRMED THAT THERE IS NO CRUSHING OR FLARING IN THE SLIDING PART, SHAFT, AND DISTAL TIP. THE LOAD AT THE TIME OF STENT RELEASE IS MEASURED ON 100% BASIS BY THE LOAD MEASURING DEVICE TO CONFIRM THAT THERE IS NO ANOMALY IN THE RELEASE RESISTANCE. IN THE HANDLE ASSEMBLING PROCESS, WHEN EACH MATERIAL (THUMBWHEEL, SPRING [MECHANISM TO UNLOCK THE THUMBWHEEL], RELEASE WIRE, AND ANTI-KINKING SLEEVE) IS ASSEMBLED, AN IMAGE DEVICE IS USED TO CHECK WHETHER EACH MATERIAL IS PROPERLY INSTALLED, AND AN IMAGE RECORD IS KEPT.
THE USER FACILITY REPORTED THAT THE MISAGO DEVICE INVOLVED WAS USED DURING A PERIPHERAL INTERVENTION OF A CHRONIC TOTAL OCCLUSION SUPERFICIAL FEMORAL ARTERY (CTO) (SFA) USING A 6 FRENCH 45-CENTIMETER DESTINATION VIA THE CONTRA LATERAL APPROACH. THE PHYSICIAN CROSSED WITH A 035 ADVANTAGE/035 NAVICROSS. AFTER CROSSING THE LESION, ORBITAL ATHERECTOMY WAS PERFORMED USING A CARDIOVASCULAR SYSTEM, INC. (CSI) DEVICE. THE VESSEL WAS PRE-DILATED USING AN ABBOTT ARMADA BALLOON. AFTER PRE DILATION, A 7/150 MISAGO STENT WAS DEPLOYED IN THE SFA SUCCESSFULLY. ONCE THE STENT CATHETER WAS REMOVED FROM THE PATIENT'S BODY, THE PHYSICIAN NOTICED A FRACTURE AROUND THE DEPLOYMENT HANDLE. THE FRACTURE AROUND THE DEPLOYMENT HANDLE DID NOT CAUSE ANY ISSUES DEPLOYING THE STENT. THE STENT WAS THEN POST DILATED USING A BALLOON. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE TYPE OF TREATMENT WAS PERIPHERAL INTERVENTION ANGIOPLASTY/ATHERECTOMY/STENT. THE LESION TREATMENT HISTORY: DISEASED LIMB RIGHT SFA, MODERATE CALCIFICATION, NO TORTUOUSNESS, TASC II CLASSIFICATION TYPE D, PRE-DILATATION: YES, POST DILATION YES. THE LESION LENGTH WAS 100 % DIAMETER, STENOSIS 100. THE VESSEL'S DIAMETER WAS APPROXIMATELY 6 MILLIMETERS (MM). THE SITE OF PUNCTURE WAS AT THE FEMORAL ARTERY, CONTRALATERAL RETROGRADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679194 | R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | TERUMO MEDICAL CORPORATION | N/A | 200924 | 04987350727787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | ARAMADA BALLOON| CSI DEVICE| METACROSS BALLOON |