BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 14633023 · Received June 8, 2022

    Report

    Report Number
    2029214-2022-00963
    Event Type
    Death
    Date Received
    June 8, 2022
    Date of Event
    May 17, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536008281
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER 2 IMPLANTED AXIUM COILS AND THE RIST CATHETER THAT WERE USED IN THE PROCEDURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING 2 AXIUM COILS THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED BASILAR TIP ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COMPLAINT DEVICES AND ALL ACCESSORIES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS PROPERLY REMOVED FROM THE HOOP AND THERE WAS NO VISIBLE DAMAGE TO THE INTRODUCER SHEATH OR COIL HOOP. ONE COIL (MODEL: APB-6-20-3D-SS, LOT: 220885243) HAD RESISTANCE IN THE SHEATH AND WAS REPLACED. ANOTHER COIL (MODEL: APB-3.5-10-3D-ES, LOT: B173249) HAD THE INTRODUCER SHEATH PROPERLY POSITIONED IN THE HUB AND PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT COULD NOT BE ADVANCED THROUGH THE HUB OF THE CATHETER. IT WAS NOTED THE DISTANCE BETWEEN THE INTRODUCER SHEATH AND THE ANGLED PORTION OF THE NON-MEDTRONIC BALLOON CATHETER WAS TOO GREAT AND THE COIL STARTED TO TAKE COILING SHAPE IN THE HUB OF THE MICROCATHETER. THE COIL WAS DAMAGED BUT THE CATHETER WAS NOT. THE COIL WAS REMOVED AND REPLACED AND OTHER COILS WERE SUCCESSFULLY DELIVERED USING THE SAME CATHETER. IT WAS NOTED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, HOWEVER, THE PATIENT DIED POST-OPERATIVELY. THE SUSPECTED CAUSE OF DEATH WAS INTRACRANIAL BLEEDING. ANCILLARY DEVICES: CORDIS RAIN SHEATH, RIST 7F GUIDE SHEATH, BALT ECLIPSE 6MM BALLOON CATHETER, SYNCHRO 14 SOFT GUIDEWIRE ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE COIL WAS PULLED BACK INSIDE DURING HYDRATION. THREE OTHER AXIUM COILS WERE IMPLANTED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PATIENT PASSED AWAY AT THE HOSPITAL. NO AUTOPSY RECORDS ARE AVAILABLE. POST-OPERATIVE INTRACRANIAL BLEEDING WAS CONFIRMED. THE E VENTS WERE NOT CONSIDERED TO BE RELATED TO THE COILS OR THE PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT PASSED AWAY AT THE (B)(6) HOSPITAL. THE DEATH WAS NOT THOUGHT TO BE RELATED TO THE MEDTRONIC DEVICE OR PROCEDURE. IT WAS INDICATED THAT THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289039 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-6-20-3D-SS 223487918 00847536008281

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Death