BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST INFLATION DEVICE 30ATM

    MDR report key: 6964690 · Received October 20, 2017

    Report

    Report Number
    1220452-2017-00105
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 22, 2017
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DTL
    UDI-DI
    00643169621916
    PMA / PMN Number
    K960983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE CINE IMAGES IT WAS CONFIRMED THAT A PERFORATION HAD OCCURRED. CINE IMAGES ANALYSIS SUMMARY: AFTER INITIAL STENT DEPLOYMENT IN THE LAD KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED BETWEEN THE DIAGONAL AND THE MAIN VESSEL. THE KBT APPEARS TO HAVE BEEN COMPLETED WITH A LOW PROFILE OUTER DIAMETER BALLOON. AFTER KBT THERE IS EVIDENCE OF CONTRAST EXITING THE VESSEL INDICATING THAT THE BALLOON HAS BURST. THIS ALSO SUGGESTS THAT THERE WAS PERFORATION TO THE VESSEL. THIS PERFORATION TO THE VESSEL WAS TREATED WITH REPEAT LESION BALLOONING AND STENT DEPLOYMENT. NO PERMANENT INJURY TO THE VESSEL IS APPARENT. THE ROOT CAUSE OF THE PERFORATION IS NOT EVIDENT FROM THE IMAGES PROVIDED. PRODUCT ANALYSIS SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. AS RECEIVED THE GAUGE NEEDLE WAS AT 0ATM. THE EVEREST SYRINGE BODY, TUBE AND LURE ROTATOR/CONNECTOR ALL APPEAR UNDAMAGED AND WITHOUT DEFECT. CLOSER VISUAL INSPECTION DETECTED NO DAMAGE TO THE GAUGE HOUSING OR THE SYRINGE BODY. DURING FUNCTIONALITY TESTING THE DEVICE ASPIRATED WATER WITH THE NEEDLE REMAINING AT 0ATM FAILING TO RETURN TO VACUUM. THE DEVICE WAS PRESSURIZED WHILE TURNING THE KNOB ONE FULL TURN, THE NEEDLE REMAINED AT 0ATM, NO MOVEMENT DETECTED ON THE NEEDLE. ANOTHER IN-HOUSE FUNCTIONAL EVEREST WAS CONNECTED SIDE BY SIDE WITH RETURNED EVEREST GAUGE AND THE RETURNED GAUGE NEEDLE REMAINED AT 0ATM WHILE THE IN-HOUSE EVEREST NEEDLE MOVED FREELY. THE GAUGE WAS REMOVED FROM THE SYRINGE BODY, CLOSER INSPECTION OF THE BORE DETECTED GLUE LIKE MATERIAL AROUND THE BORE AT THE BOTTOM ON THE METAL FILTER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE AN EVEREST INFLATION DEVICE TO TREAT A LESION IN THE DIAGONAL BRANCH WITH 60% STENOSIS. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU. THE DEVICE WAS CONNECTED TO A BALLOON CATHETER. IT IS REPORTED THAT NO SIGNAL OF INCREASING PRESSURE DISPLAYED ON THE DEVICE AND THE BALLOON BURST IN THE ARTERY. NO PATIENT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745232 EVEREST INFLATION DEVICE 30ATM ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL MEDTRONIC, INC 51026713 00643169621916

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention