BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM 3D

    MDR report key: 22986603 · Received September 5, 2025

    Report

    Report Number
    9617601-2025-01347
    Event Type
    Death
    Date Received
    September 5, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 15, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00847536037816
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    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 WAS RECEIVED STATING THAT THE PATIENT PASSED AWAY ON (B)(6) 2025. AUTOPSY RECORDS ARE NOT AVAILABLE. REGARDING THE CAUSE OF DEATH AND ANY RELEVANT MEDICAL EVENTS LEADING UP TO THE PATIENT'S PASSING, IT WAS NOTED THAT THE PATIENT HAD AN UNDERLYING POOR GRADE SUBARACHNOID HEMORRHAGE (WFNS GRADE 5) WITH HIGH LIKELIHOOD OF MORBIDITY AND MORTALITY. THE STRETCHED COIL WHICH LEAD TO COMPLICATIONS OF CAUSING PARENT VESSEL OCCLUSION AND SUBSEQUENT INTERNAL CAROTID ARTERY (ICA) TERRITORY INFARCTION WOULD HAVE CONTRIBUTED TO THE POOR OUTCOME. IT WAS CONFIRMED THAT THE COIL PROTRUDED INTO THE PARENT ARTERY (A1 ANTERIOR CEREBRAL ARTERY SEGMENT, AND INTERNAL CAROTID ARTERY) DURING THE PROCEDURE. PATIENT HAD INTERMEDIATE TORTUOSITY. THE CAUSE OF THE COIL STRETCH WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING THE AXIUM QC COIL, THE DEVICE EXPERIENCED COIL STRETCH. IT WAS REPORTED THAT THE COIL WAS IMPLANTED, AND THE PATIENT WAS "RIP". IT WAS UNKNOWN IF THERE WAS ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS CONFIRMED THE PATIENT PASSED AWAY. THERE CAUSE OF DEATH WAS UNKNOWN AT THIS TIME, THOUGH IT WAS NOTED THAT THERE IS NO CURRENT EVIDENCE TO SUGGEST THAT THE DEATH WAS RELATED TO THE MEDTRONIC DEVICE OR THERAPY. THE PATIENT HAD UNDERWENT ANGIOGRAM AND COIL EMBOLIZATION FOR A 7×5×4 MM IRREGULAR, LOBULATED, WIDE-NECKED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM (NECK 3.5 MM), ARISING FROM LEFT A1 ACA SEGMENT. THE COIL STRETCH OCCURRED DURING THE PROCEDURE WHEN ATTEMPTING TO REMOVE A PROMINENT COIL LOOP PROTRUDING INTO THE LEFT A1/A2 JUNCTION. THE STRETCHED COIL WAS ULTIMATELY REMOVED USING COMBINED ASPIRATION AND A TIGERTRIEVER XL AND WAS NOT IMPLANTED. THE COIL STRETCH OCCURRED DUE TO REPEATED MANIPULATION AND TRACTION DURING MULTIPLE RETRIEVAL ATTEMPTS AFTER BALLOON-ASSISTED ADJUSTMENT FAILED TO RESOLVE THE PROMINENT LOOP AT THE A1/A2 JUNCTION. THE COIL LOOP DID PROTRUDE INTO THE PARENT ARTERY DURING THE EVENT. THE DEVICE DAMAGE CAUSE WAS RELATED TO MECHANICAL STRESS DURING COMPLEX RETRIEVAL AND DEVICE EXCHANGES IN THE INTRA-PROCEDURAL MANAGEMENT OF THE COIL LOOP. THERE WERE NO ADDITIONAL POST-PROCEDURE EVENTS OR DOSE CHANGES. IT WAS NOTED THERE WAS MILD VASOSPASM OF THE PROXIMAL A2 ANTERIOR CEREBRAL ARTERY (ACA) SEGMENTS BILATERALLY. THERE WAS MINIMAL TO NORMAL VESSEL TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237594 AXIUM 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV QC-5-15-3D 229753347 00847536037816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death