BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROFRAME 10 ADVANCED

    MDR report key: 12072039 · Received June 25, 2021

    Report

    Report Number
    2032493-2021-00238
    Event Type
    Death
    Date Received
    June 25, 2021
    Date of Event
    May 16, 2021
    Report Date
    October 2, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00816777023681
    PMA / PMN Number
    K161367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE DEVICE EVALUATION RESULTS. ADDITIONAL INFORMATION: D10 (DATE DEVICE RETURNED), H6, H11 (DEVICE EVALUATION). ITEMS RETURNED FOR EVALUATION: PUSHER. ITEMS NOT RETURNED FOR EVALUATION: IMPLANT, INTRODUCER, DISPENSER, MICROCATHETER. INVESTIGATION FINDINGS: THE DEVICE WAS RETURNED WITHOUT THE IMPLANT ATTACHED, AND NO SIGNS OF ACTIVATION USING A DETACHMENT CONTROLLER WERE OBSERVED ON THE PUSHER HEATER COIL. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE PUSHER'S ATTACHMENT GLUE BOND WAS MEASURED USING THE KEYENCE AND FOUND TO BE WITHIN SPECIFICATION. FURTHER INSPECTION FOUND THAT THE PUSHER BODY COIL EXHIBITED STRETCHING AT 7CM, 8CM, AND 22CM FROM THE PUSHER DISTAL TIP, OFFSET AT 26CM AND 27CM FROM THE PUSHER DISTAL TIP, AND STRETCHING WITH THE LEAD WIRES BROKEN AND EXPOSED AT THE TRANSITION AREA. NO OTHER DAMAGE WAS OBSERVED. INVESTIGATION CONCLUSION: THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THAT THE PUSHER WAS RETURNED WITHOUT THE IMPLANT ATTACHED; THE HEATER COIL DISPLAYED NO INDICATION OF ACTIVATION USING A DETACHMENT CONTROLLER. THE IMPLANT WAS NOT RETURNED AND, THEREFORE, COULD NOT BE EVALUATED. FURTHER INSPECTION FOUND THAT THE PUSHER BODY COIL WAS STRETCHED AT 7CM, 8CM, AND 22CM FROM THE PUSHER DISTAL TIP, OFFSET AT 26CM AND 27CM FROM THE PUSHER DISTAL TIP, AND STRETCHED WITH THE LEAD WIRES BROKEN AND EXPOSED AT THE TRANSITION AREA. THESE CONDITIONS FOUND DURING THE EVALUATION ARE CONSISTENT WITH THE COIL SYSTEM EXPERIENCING INCREASED TENSILE/RETRACTION FORCE, WHICH WOULD ALSO LEAD TO THE IMPLANT FORCIBLY SEPARATING FROM THE PUSHER. NO DESTRUCTIVE TESTING WAS PERFORMED; HOWEVER, DESTRUCTIVE TESTING MAY BE PERFORMED UPON REQUEST. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED, SO THE INVESTIGATION COULD NOT FURTHER EVALUATE THE MICROCATHETER. MICROVENTION 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 MICROVENTION, WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MICROVENTION 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, MICROVENTION, OR ITS EMPLOYEES THAT THE DEVICE, MICROVENTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. 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.

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEATH AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EMBOLIZATION COILS WERE USED TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) CAUSED BY RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY (ACOM). SEVERAL COILS OF DIFFERENT SIZES WERE ATTEMPTED BY THE PHYSICIAN, WITHOUT SUCCESS. AFTER MULTIPLE MANIPULATIONS, ONE OF THE COILS STRETCHED DURING PARTIAL DEPLOYMENT TO A POINT WHERE THE PHYSICIAN WAS NOT ABLE TO REMOVE IT. STENTS WERE PLACED AND THE ACOM ARTERY WAS REPORTEDLY OCCLUDED, BUT THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968018 HYDROFRAME 10 ADVANCED VASCULAR EMBOLIZATION DEVIC KRD MICROVENTION, INC. 7110-0515-A2 1902141WF 00816777023681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death