BEUDAMED
    FDA Adverse Event Death Summary report: N

    D'VILL INTRODUCER

    MDR report key: 8842245 · Received July 30, 2019

    Report

    Report Number
    1318694-2019-00017
    Event Type
    Death
    Date Received
    July 30, 2019
    Date of Event
    July 13, 2019
    Report Date
    July 30, 2019
    Manufacturer
    NUMED, INC.
    Product Code
    DYB
    PMA / PMN Number
    K171206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INTRODUCER AND DILATOR WERE RETURNED IN A PLASTIC BAG. THE PARTS ARE BLOODY. A 15.5CM SECTION OF THE SHEATH HAS BEEN CUT OFF. THE REMAINDER OF THE SHEATH HAS BEEN SLICED OPEN. THE HEMOSTASIS VALVE HOUSING HAS BEEN REMOVED FROM THE SHEATH. THE VALVE IS MISSING FROM THE HOUSING. THE VALVE WAS LOCATED IN THE 15.5CM SECTION OF THE SHEATH. THE VALVE WAS LODGED IN THE SHEATH IN A MANNER THAT WOULD NOT ALLOW THE DILATOR TO PASS THROUGH THE SHEATH. THE VALVE WAS REMOVED FROM THE SHEATH WITH A 0.110" ROD. THE VALVE IS INTACT. A COMPARATIVE D'VILL WAS TESTED. A GUIDEWIRE WAS PASSED THROUGH THE SHEATH. THE DILATOR WAS THEN PASSED THROUGH THE HEMOSTASIS VALVE AND SHEATH WITH NO PROBLEM. THE DILATOR WAS REMOVED AND THE SHEATH WAS LEAK TESTED AT 1 ATM. THE GASKET DID NOT LEAK. THE COMPLAINT IS CONFIRMED. IT APPEARS THAT THE HEMOSTASIS VALVE BECAME DISLODGED WHEN THE DILATOR WAS INSERTED INTO THE SHEATH. AS PART OF FINAL QC INSPECTION, THE GASKET IS INSPECTED TO VERIFY THAT THE INNER GASKET IS INSIDE THE VALVE BODY AND PROPERLY SEATED, THERE IS A SMALL OPENING IN THE GASKET, THERE IS A TUG TEST PERFORMED HOLDING THE VALVE AND THE SHEATH TO MAKE SURE THERE IS NO MOVEMENT, THE HEMOSTASIS VALVE IS IMMERSED INTO A WATER BATH TO CHECK FOR GASKET LEAKAGE. THIS INTRODUCER PASSED ALL OF THE INSPECTION CRITERIA. THIS PHYSICIAN WAS A FIRST-TIME USER OF THIS DEVICE. AS PER THE PHYSICIAN IT WAS A VERY COMPLEX, HIGH-RISK CASE AND IT WAS AN EMERGENCY PROCEDURE. AS PER THE PHYSICIAN HE TRIED TO INSERT A LARGER SHEATH THAT IS USUALLY USED IN EVAR. WHEN THIS NEW SHEATH (AFX - ENDOLOGIX, 17F INTERNAL DIAMETER) WAS BEING ADVANCED, THE FRICTION AND TORTUOSITY OF THE ILIAC VESSELS MADE THE PROCEDURE VERY COMPLEX TECHNICALLY, WHICH CAUSED STRESS TO THE ENDOPROSTHESIS THAT PREVIOUSLY HAD BEEN IMPLANTED IN THE PATIENT. THIS CAUSED THE SECTIONS (OF THE ENDOPROSTHESIS) TO DISENGAGE (DISCONNECT) AND THE PATIENT DECOMPENSATED IN SUCH A WAY THAT ALL THE EFFORTS MADE BY THE MEDICAL TEAM WERE NOT SUCCESSFUL AND THE PATIENT UNFORTUNATELY DIED. THE WARNINGS IN THE IFU STATES "THE MAXIMUM DIAMETER OF THE DEVICE TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE PASSAGE THROUGH THE SHEATH. ALL DEVICES USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE SHEATH MAY RESULT WHEN THE FIT IS TIGHT. IF VESSEL SIZE IS SMALLER THAN THE INTRODUCER SHEATH OUTER DIAMETER, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT. DO NOT ADVANCE THE SHEATH OR ANY OTHER COMPONENT IF RESISTANCE IS MET, WITHOUT FIRST DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION." THE PRECAUTIONS IN THE IFU STATES "UNDER NO CIRCUMSTANCES SHOULD ANY PORTION OF THE INTRODUCER BE ADVANCED AGAINST RESISTANCE. THE CAUSE OF THE RESISTANCE SHOULD BE IDENTIFIED WITH FLUOROSCOPY AND ACTION TAKEN TO REMEDY THE PROBLEM. IF RESISTANCE IS FELT UPON REMOVAL, ALL COMPONENTS SHOULD BE REMOVED TOGETHER AS A UNIT, USING A GENTLE TWISTING MOTION COMBINED WITH TRACTION." THE COMPARATIVE D'VILL PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THIS INCIDENT WAS FIRST REPORTED TO NUMED VIA EMAIL AND ON NUMED'S PRODUCT INCIDENT REPORT. NUMED REQUESTED ADDITIONAL INFORMATION DUE TO THE WAY THAT IT WAS ORIGINALLY WRITTEN ON THE PRODUCT INCIDENT REPORT. BELOW IS THE ADDITIONAL INFORMATION / CLARIFICATIONS ON THE ISSUE: WHEN PREPARING THE DVILL SHEATH, THE OPERATOR NOTICED RESISTANCE IN THE PASSAGE OF THE DILATOR THROUGH THE VALVE OF THE SHEATH, SO MUCH SO THAT HE ONLY MANAGED TO INTRODUCE THE DILATOR HALFWAY UP THE SHEATH. DUE TO THIS (RESISTANCE), HE HAD TO APPLY MORE PRESSURE TO BE ABLE TO ADVANCE THE DILATOR AND EXPOSE IT AT THE TIP OF THE SHEATH. THE SHEATH ALREADY ASSEMBLED WITH THE DILATOR ADVANCED WITHOUT PROBLEMS THROUGH THE LUNDER GUIDE TO THE AREA THAT THE DOCTOR WANTED TO POSITION THE COVERED STENT. WHEN REMOVING THE DILATOR FROM THE SHEATH ... AGAIN HE DID IT WITH EFFORT ... AND WHEN REMOVING THE DILATOR COMPLETELY, BLEEDING STARTED, NOT REGULATED(UNCONTROLLED) BY THE LUMEN OF THE DVILL SHEATH, WHICH WAS INTERPRETED AS A PROBLEM WITH THE VALVE, IN THAT MINUTE THE PATIENT BLED ABUNDANTLY AND THE MEDICAL TEAM MANAGED TO CONTROL TO TRY TO IMPLANT THE STENT AND REDUCE THE BLEEDING, THEY TRIED TO INTRODUCE THE COVERED STENT, WHICH COULD NOT BE ACCOMPLISHED, BECAUSE, IT WAS IMPOSSIBLE TO ENTER THE AREA(SECTION OF THE SHEATH), WHERE THE VALVE SHOULD BE. IT WAS NOT CLEAR WHAT WAS HAPPENING WITH THE VALVE, AT THIS POINT. IT SEEMS THAT WHEN (THE DOCTOR) TRIED TO INTRODUCE THE PEEL AWAY FROM THE AORTIC BEGRAFT, IT WAS NOT POSSIBLE BECAUSE THERE WAS AN "ELEMENT" WHICH WAS OBSTRUCTING THE ACCESS. PROBABLY, IT WAS THE VALVE THAT WAS BROKEN(DEFECTIVE). THE MEDICAL TEAM ASSUMED THAT THE VALVE IS DAMAGED AND CUT THE D'VILL SHEATH AND ACCESS FOR THE STENT (TO PASS) BECAME OPEN. WITHOUT THE VALVE, THE BLEEDING WAS REACTIVATED (RESTARTED) ... AND THEY DID NOT INSIST ON INSERTING THE STENT, THEY JUST CHANGED THEIR PLANS AND TOOK OUT THE REST OF THE D'VILL SHEATH AND TRIED TO INSERT A LARGER SHEATH THAT IS USUALLY USED IN EVAR WHEN THIS NEW SHEATH WAS BEING ADVANCED, THE FRICTION AND TORTUOSITY OF THE ILIAC VESSELS MADE THE PROCEDURE VERY COMPLEX TECHNICALLY, WHICH CAUSED STRESS TO THE ENDOPROSTHESIS THAT PREVIOUSLY HAD BEEN IMPLANTED IN THE PATIENT. THIS CAUSED THE SECTIONS ( OF THE ENDOPROSTHESIS) TO DISENGAGE(DISCONNECT) AND THE PATIENT DECOMPENSATED IN SUCH A WAY THAT ALL THE EFFORTS MADE BY THE MEDICAL TEAM WERE NOT SUCCESSFUL AND THE PATIENT UNFORTUNATELY DIED IT WAS A VERY COMPLEX, HIGH-RISK CASE AND IT WAS AN EMERGENCY PROCEDURE EVERYONE INVOLVED WAS INFORMED OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634751 D'VILL INTRODUCER INTRODUCER DYB NUMED, INC. 700 DV-0168

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Death