BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHERA

    MDR report key: 21072418 · Received January 3, 2025

    Report

    Report Number
    2029214-2025-00033
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    October 21, 2024
    Report Date
    January 27, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: OK, T., YOON, P. H., <(>&<)> SEO, K.-D.. INADVERTENT DETACHMENT OF STENT RETRIEVERS: REPORT OF 2 CASES. NEURO INTERVENTION 19(3):180-184. 2024. DOI:10.5469/NEUROINT.2024.00409 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SIDE EFFECT OF THE STENT RETRIEVER, SPECIFICALLY INADVERTENT STENT DETACHMENT AS MENTIONED IN THE PAPER, IS NOT RELATED TO THE MICROCATHETER OR/AND BALLOON GUIDING CATHETER FROM MEDTRONIC.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING "INADVERTENT DETACHMENT OF STENT RETRIEVERS: REPORT OF 2 CASES". THE OBJECTIVE IS TO PRESENT AND ANALYZE TWO CASES OF INADVERTENT STENT DETACHMENT DURING MECHANICAL THROMBECTOMY UTILIZING THE PRESET STENT (PHENOX). MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PHENOM 21 MICROCATHETERS AND A CELLO BALLOON GUIDE CATHETER NO DEATH WAS MENTIONED IN THE STUDY ADVERSE EVENTS: -CASE 1 HAD UNSUCCESSFUL RECANALIZATION. THE ASPIRATION CATHETER WAS ADVANCED INTO THE OCCLUDED SEGMENT WITHIN THE STENT, AND CONTACT ASPIRATION THROMBECTOMY WAS PERFORMED 3 TIMES, THOUGH RECANALIZATION REMAINED UNSUCCESSFUL. SUBSEQUENTLY, 1 MG OF TIROFIBAN WAS ADMINISTERED INTRA-ARTERIALLY. A MICROWIRE WAS NAVIGATED THROUGH THE DETACHED STENT, FOLLOWED BY ADVANCEMENT OF THE 3×15 MM GATEWAY BALLOON CATHETER (STRYKER) OVER THE WIRE. FOLLOWING BALLOON ANGIOPLASTY USING A BALLOON CATHETER, FINAL ANGIOGRAPHY REVEALED RECANALIZATION OF THE RIGHT MCA WITH AN EXPANDED THROMBOLYSIS IN CEREBRAL INFARCTION (ETICI) SCORE OF 2B67. THE PATIENT IMPROVED, SCORING 6 POINTS ON THE NIHSS AND MODIFIED RANKIN SCALE (MRS) OF 3 AT 8 DAYS POST-PROCEDURE -IN CASE 2, NO RECANALIZATION WAS ACHIEVED. DURING THE THIRD ATTEMPT, THE NON-MEDTRONIC STENT DETACHED UNINTENTIONALLY. DURING THE STENT RETRIEVAL PROCESS, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, INDICATING A POTENTIAL RISK OF VESSEL INJURY. THE PROCEDURE WAS TERMINATED AS THE MICROCATHETER COULD NOT TRAVERSE THE DETACHED STENT. THE FINAL ETICI SCORE WAS 1. THE PATIENT WAS TRANSFERRED TO THE REHABILITATION DEPARTMENT 1 MONTH LATER WITH AN NIHSS SCORE OF 12 AND MRS OF 5. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639270 CATHERA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG13 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| S SEE H11...