BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 19928839 · Received August 7, 2024

    Report

    Report Number
    2029214-2024-01387
    Event Type
    Death
    Date Received
    August 7, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: SAB-6-30 (LOT: B518292). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING TWO SOLITAIRE STENT RETRIEVERS WHICH BROKE/DETACHED UNINTENTIONALLY WITHIN THE PATIENT'S BODY. THE 83 YEAR OLD MALE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE. THE OCCLUSION WAS LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). BASELINE MRS WAS 5, NIHSS WAS 10, AND TICI WAS 0. IV TPA WAS NOT CONTRAINDICATED. IT WAS NOTED THAT PATIENT VESSEL TORTUOSITY WAS EXTREMELY SEVERE BUT THE PATIENT DID NOT HAVE VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). FIRST THE SOLITAIRE FR (SFR-6-30) WAS USED. IT WAS NOTED THE ATTEMPT WAS TO USE THE STENT RIVETS TO CARRY THE INTERMEDIATE CATHETER UP BUT THE STENT BROKE/ACCIDENTALLY DETACHED INSIDE THE PATIENT'S BODY. A SOLITAIRE AB (SAB-6-30) WAS THEN TRIED BUT IT TOO BROKE OFF IN THE BLOOD VESSEL "AFTER BEING PULLED APART." ONLY 1 PASS WAS MADE WITH EACH SOLITAIRE. THERE WAS NO REPORTED FRICTION OR OTHER DIFFICULTY. THE STENT PROXIMAL MARKER WAS NOT COVERED BY THE MICROCATHETER TIP DURING RETRIEVAL. THE PUSHWIRE WAS NOT TORQUED. THE SURGEON USED A SNARE/SPIDER TO TRY AND RETRIEVE THE SEPARATED STENT. DESPITE SEVERAL HOURS OF TRYING, THE SOLITAIRES COULD NOT BE RETRIEVED SO THE ATTEMPT WAS ABANDONED. BOTH SOLITAIRE STENTS REMAIN IN THE PATIENT'S RIGHT MCA.  POST-PROCEDURE MRS REMAINED 5, NIHSS REMAINED 10, AND TICI REMAINED 0. IT WAS NOTED THE PATIENT'S PUPILS BECAME ENLARGED. THE PATIENT WAS DISCHARGED HOME TO FAMILY AND IT WAS NOTED THE PATIENT PASSED  AWAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEATH WAS NOT THOUGHT TO BE RELATED TO THE MEDTRONIC DEVICE OR THERAPY. THE PATIENT¿S CONDITION WAS UNKNOWN AFTER DISCHARGE AND COULD NOT BE CONTACTED, AND THE OCCLUDED PART COULD NOT BE UNBLOCKED. THE CLOT COULD NOT BE REMOVED FROM THE BLOOD VESSEL. THE INSTRUMENT COULD NOT ENTER, SO THE CHARACTERISTICS OF THE CLOT WERE UNKNOWN. THE CAUSE OF THE SOLITAIRE BREAK/SEPARATION WERE NOT DETERMINED. THE INITIAL ESTIMATE WAS THAT IT MAY HAVE BEEN THAT THE BLOOD VESSELS WERE EXTREMELY TORTUOUS, RESULTING IN MANUAL DETACHMENT OF THE DETACHMENT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219503 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B509819

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death SEE H11.