BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R2P MISAGO

    MDR report key: 22391639 · Received July 2, 2025

    Report

    Report Number
    9681834-2025-00115
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 2, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    NIP
    UDI-DI
    04987350727749
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: PHONE NUMBER: REQUESTED, NOT PROVIDED. 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. THE HISTORICAL INVESTIGATION REVEALED NO ANOMALIES IN THE MANUFACTURING AND PRODUCT INSPECTION RECORDS FOR THE PRODUCT WITH THE SPECIFIED CODE/LOT NUMBER. ADDITIONALLY, NO SIMILAR REPORTS HAVE BEEN IDENTIFIED FOR THIS PRODUCT CODE/LOT NUMBER IN THE PAST. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4). PLEASE REFER TO SECTION H10 FOR THE IMPORTER'S REPORT ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION ON THE ACTUAL DEVICE COULD NOT BE CONDUCTED. A HISTORICAL INVESTIGATION WAS CONDUCTED FOR THE PRODUCT ASSOCIATED WITH THE REPORTED PRODUCT CODE AND LOT NUMBER. NO ANOMALIES WERE FOUND IN THE MANUFACTURING RECORD OR THE PRODUCT INSPECTION RECORD. ADDITIONALLY, NO OTHER SIMILAR REPORTS WERE FOUND IN THE PAST COMPLAINT FILES FOR THE SAME PRODUCT CODE AND LOT NUMBER. THIS PRODUCT HAS A STRUCTURE IN WHICH THE STENT SELF-DILATES BY ROTATING THE THUMBWHEEL, WINDING THE RELEASE WIRE CONNECTED TO THE SLIDING PART, AND PULLING THE SLIDING PART TOWARD THE PROXIMAL END. IF THE STENT IS RELEASED WHILE THE SLIDING PART OF THE DELIVERY CATHETER IS TRAPPED, THE SLIDING PART IS HINDERED FROM MOVING PROXIMALLY. IN THIS SITUATION, ONLY THE RELEASE WIRE IS WOUND, COMPRESSIVE FORCE IS APPLIED TO THE PROXIMAL SHAFT LOCATED OUTSIDE THE PATIENT'S BODY, AND WAVINESS OCCURS. FURTHERMORE, WHEN THE FORCE TRAPPING THE SLIDING PART IS GREATER THAN THE FORCE PULLING IT PROXIMALLY, A FORCE PUSHING OUT THE INNER SHAFT IS GENERATED, AND THE INNER SHAFT (CONTRAST MARKER) ADVANCES. AS A RESULT, THE STENT DEPLOYED FROM THE SLIDING PART IS PUSHED OUT BY THE PROXIMAL MARKER ON THE INNER SHAFT, COMPRESSIVE FORCE IS APPLIED, AND THE STENT CONTRACTS (SHORTENS). THESE EVENTS MAY BE PREVENTED BY PROPERLY HOLDING THE CATHETER. REGARDING THE CAUSE OF BOTH MANUFACTURER REPORT NUMBERS 9681834-2025-00114 AND 9681834-2025-00115, THE FOLLOWING FACTOR WAS INFERRED. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. WHILE RELEASING THE STENT, THE SLIDING PART OF THE ACTUAL DEVICE (THE SECTION WHERE THE STENT WAS MOUNTED) WAS TRAPPED BY A HARD OBJECT, SUCH AS A CALCIFIED LESION, PREVENTING THE SLIDING PART FROM BEING PULLED PROXIMALLY. AT THAT TIME, DUE TO INSUFFICIENT HOLD ON THE DELIVERY CATHETER, COMPRESSIVE FORCE WAS APPLIED TO THE SHAFT LOCATED OUTSIDE THE PATIENT'S BODY, CAUSING IT TO WAVE. SINCE THE SLIDING PART WAS HINDERED FROM MOVING PROXIMALLY, A FORCE PUSHING OUT THE INNER SHAFT WAS GENERATED, AND THE INNER SHAFT (CONTRAST MARKER) ADVANCED. CONSEQUENTLY, THE STENT DEPLOYED WAS PUSHED OUT BY THE PROXIMAL MARKER ON THE INNER SHAFT, COMPRESSIVE FORCE WAS APPLIED, AND THE STENT CONTRACTED (SHORTENED). REGARDING THE CAUSE OF MANUFACTURER REPORT NUMBER 9681834-2025-00115, SINCE IT WAS REPORTED THAT "EDGES OF THE STENT APPEARED INWARD," IT WAS INFERRED THAT THE STENT CONTRACTED (SHORTENED), ALTHOUGH TO A LESSER EXTENT THAN MANUFACTURER REPORT NUMBER 9681834-2025-00114. FOR FUTURE USE, THE FOLLOWING DIRECTION FOR USE DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) SHOULD BE OBSERVED: 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. THE ASHITAKA FACTORY HAS IMPLEMENTED QUALITY CONTROL MEASURES TO MAINTAIN PRODUCT QUALITY THROUGH THE FOLLOWING INSPECTIONS. AFTER PROCESSING THE STENT, 100% INSPECTION USING AN IMAGING DEVICE IS PERFORMED TO CONFIRM THAT THE STENT STRUT IS NOT DEFORMED OR FRACTURED. THE WIDTH AND THICKNESS OF THE STENT STRUT ARE ALSO CONFIRMED THROUGH 100% IMAGING INSPECTION. AFTER MOUNTING THE STENT ON THE DELIVERY CATHETER, THE STENT LENGTH IS MEASURED ON A 100% BASIS. A 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO OVERLAPPING, DEFORMATION, OR FRACTURE, AND THAT THERE ARE NO KINKS OR CRUSHING ON THE SLIDING PART OR SHAFT. ADDITIONALLY, THE LOAD APPLIED DURING STENT RELEASE IS MEASURED USING A LOAD MEASURING DEVICE ON A 100% BASIS TO CONFIRM THAT THERE IS NO ANOMALY IN RELEASE RESISTANCE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT POST-DEPLOYMENT OF TWO MISAGO STENTS (6X150 UNITS) IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE PROXIMAL STENT WAS CONSIDERED TO BE CRIMPED, WITH THE EDGES OF THE STENT APPEARING INWARD. THE DISTAL STENT, ALSO 6X150 (SAME LOT NUMBER), WAS FORESHORTENED UPON DEPLOYMENT. AFTER DEPLOYMENT OF BOTH STENTS, THERE WAS NO FLOW THROUGH THE STENTS, AND THE PATIENT BEGAN TO SHOW CLOTS THROUGHOUT THE LEG. THE PHYSICIAN HAD DIFFICULTY CANNULATING THE PROXIMAL STENT DUE TO THE EDGES APPEARING CRIMPED. THE TYPE OF PROCEDURE PERFORMED WAS AN SFA PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVELY. ESTIMATED BLOOD LOSS WAS NONE. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR POSSIBLE CLOT ASPIRATION OR BYPASS. ADDITIONAL INFORMATION RECEIVED ON 10 JUN 2025: INDICATED THAT IN ADDITIONAL SURGICAL/MEDICAL PROCEDURES PERFORMED AFTER THE STENT SHRINKAGE, THE LYSIS CATHETER WAS INSERTED IN A SUBSEQUENT PROCEDURE. THE PATIENT IS STABLE AND DOING WELL ACCORDING TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201591 R2P MISAGO STENT, SUPERFICIAL FEMORAL ARTERY NIP TERUMO CORPORATION, ASHITAKA SXR06150R 240807 04987350727749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention