BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 9917757 · Received April 2, 2020

    Report

    Report Number
    3004193842-2020-00007
    Event Type
    Death
    Date Received
    April 2, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 2, 2020
    Manufacturer
    CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
    Product Code
    DYB
    UDI-DI
    05391526210116
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR CREGANNA MEDICAL FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION, IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY PRODUCT ANALYSIS REVIEW INCLUDING DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION AND THEREFORE, THE REPORTED COMPLAINT EVENTS COULD NOT BE DEFINITIVELY CONFIRMED. SHOULD THE COMPLAINT DEVICE BE RETURNED TO CREGANNA MEDICAL, A FOLLOW UP MDR REPORT WILL BE FILED WITH THE FDA. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 12694 AND ALL OF ITS SUBCOMPONENTS WAS COMPLETED AND FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE REVIEW OF THE ROUTER AND SUBSEQUENT SUB ASSEMBLY ROUTERS DID NOT HIGHLIGHT ANY ANOMALIES. AS OF 31-MAR-2020, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 0000012694 FOR PATIENT VESSEL PERFORATION OR PATIENT DEATH. A REVIEW OF RISK MANAGEMENT DOCUMENTATION WAS COMPLETED. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THE COMPLAINT EVENTS. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH DEVICE. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE INDICATING THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. WHILE THE COMPLAINT DESCRIPTION INDICATES A REVIEW OF THE COMPLAINT EVENTS AND 3MENSIO FILE WAS COMPLETED BY CREGANNA MEDICAL CLINICIAN AND THE CLINICIAN'S CONCLUSION WERE AS FOLLOWS: 'SINCE THE USER CHOSE TO USE THE LEFT ILIAC, IT IS ASSUMED IT WAS BECAUSE IT WAS EITHER STRAIGHTER, LARGER OR LESS DISEASED THAN THE RIGHT BUT WE KNOW WE HAVE SEEN PROBLEMS WITH VESSEL SIZE AND THIS TYPE OF COMPLICATION RELATED TO THE LIS. WITHOUT AT LEAST SOME INFORMATION ABOUT THE VASCULATURE, IT IS DIFFICULT TO KNOW IF THIS WAS AN EXPECTED COMPLICATION (WHICH IT MAY BE) OR SOMETHING DIRECTLY RELATED TO THE SHEATH (SPASM FOR EXAMPLE IN AN OTHERWISE LARGE ENOUGH VESSEL WITHOUT SIGNIFICANT DISEASE). ALTHOUGH THEY TREATED THIS AS SPASM INITIALLY, FROM THE DESCRIPTION THAT THEY HAD ANGIOGRAPHIC EVIDENCE CONFIRMING THAT AND IT WAS ONLY LATER THAT THEY SHOWED THAT THE VESSEL WAS DISRUPTED. THIS COULD HAVE ALSO BEEN A CONSEQUENCE OF THEIR REMOVAL ATTEMPTS BUT AGAIN, WITHOUT THE ANGIOGRAMS INITIALLY SHOWING SOMETHING OTHER THAN VESSEL DISRUPTION, IT MAY BE DIFFICULT TO SAY. FROM THE 3 MENSIO FILE, IT LOOKS LIKE THE RIGHT WAS CLEARLY TOO SMALL WHICH IS WHY THEY USED THE LEFT. THE DIMENSIONS ON THE LEFT WERE AT BEST BORDERLINE (AVERAGE 6.5) BUT THERE DIDN'T SEEM TO BE A GREAT DEAL OF CALCIFICATION, EXCEPT AT THE ILIAC BIFURCATION. THEREFORE, IT COULD HAVE GONE EITHER WAY ON THE ATTRIBUTION. WITH THE BORDERLINE SIZES, IT WOULD BE AN EXPECTED COMPLICATION THOUGH.' FOLLOWING THE INVESTIGATION CONCLUSION, THE COMPLIANT ANALYSED CLASSIFICATION IS ASSIGNED AS 'PRODUCT NOT RETURNED - COMPLAINT UNABLE TO CONFIRM.' BASED ON THE INITIAL INFORMATION RECEIVED AND THE ADDITIONAL CLINICAL REVIEW COMPLETED BY CREGANNA MEDICAL CLINICIAN THE PROBABLE INVESTIGATION CONCLUSION CODE ASSIGNED TO THIS COMPLAINT IS 'KNOWN INHERENT RISK OF DEVICE' DEFINED AS 'REPORTED ADVERSE EVENT KNOWN AND DOCUMENTED IN THE LABELLING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS)'. VESSEL PERFORATION OR DISSECTION ARE ANTICIPATED PROCEDURAL COMPLICATIONS AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE DEVICE INSTRUCTIONS FOR USE. UPON REVIEW OF THE ABOVE INFORMATION, ESCALATION IS REQUIRED TO QUALITY MANAGEMENT TEAM. CREGANNA MEDICAL WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS EVENTS.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: LOTUS 23MM VALVE SUCCESSFULLY IMPLANTED WITH NO PVL. WHEN THE PHYSICIAN ATTEMPTED TO TAKE OUT THE LIS, IT WAS FROZEN IN THE VESSEL. VASOSPASM SUSPECTED. SHEATH WAS PARTIALLY REMOVED BUT EVIDENCE OF VESSEL DISRUPTION WAS APPARENT. VIABAHN COVERED STENTS WERE PLACED IN THE EXTERNAL AND COMMON ILIAC ARTERIES. PATIENT CONTINUED TO BLEED. PATIENT MOVED TO THE OR FOR SURGICAL REPAIR OF THE ILIACS WHERE PATIENT EXPIRED. EVENT DATE: (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 12TH OF MARCH 2020: OPERATOR 2 WAS RUSSELL STAHL. LOTUS INTRODUCER LOT NUMBER: 0000012694. WAS THERE DIFFICULTY ADVANCING THE LOTUS EDGE? NO. WAS THERE DIFFICULTY REMOVING THE LOTUS EDGE? NO. WAS THE LOTUS EDGE ABLE TO BE REMOVED THROUGH THE LOTUS INTRODUCER? YES. WAS LOTUS EDGE REMOVED BEFORE THE VASOSPASM? YES. WHERE WAS THE SPASM? LEFT ILIACS. CAN YOU FURTHER DESCRIBE THE ''VESSEL DISRUPTION'? (PERFORATION, DISSECTION): APPEARED TO BE EVULSION OF THE ILIACS. WAS THE 'VESSEL DISRUPTION' A RESULT OF THE VASOSPASM AROUND THE LOTUS INTRODUCER SHEATH? WE BELIEVE, A PHYSICIAN WILL NEED TO COMMENT ON THAT. DID THE LOTUS EDGE VALVE CAUSE OR CONTRIBUTE TO THE 'VESSEL DISRUPTION'? THE PATIENT'S ARTERY APPEARED TO BE GLUED TO THE LIS. RETRACTION WAS ALMOST IMPOSSIBLE. PHYSICIANS GAVE BOLUSES OF PROPOFOL AND VERAPAMIL TO HELP WITH RETRACTION OF THE SHEATH. WAS THE SHEATH SURGICALLY REMOVED? YES. WILL THE LOTUS EDGE BE RETURNED FOR EVALUATION? NO. WILL THE LOTUS INTRODUCER BE RETURNED FOR EVALUATION? THAT IS THE PLAN. WE ARE AWAITING THE RETURN AS IT WAS STILL IN THE OR WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 23RD OF MARCH 2020: EVERYTHING WENT VERY WELL AT THE START. THEY CHOSE THE LEFT LEG OVER THE RIGHT. THE LIS ADVANCED WITH NO RESTRICTIONS NOTED. NO REQUIREMENT TO PERFORM A DILATION. NO DIFFICULTIES ADVANCING. DURING DEPLOYMENT OF THE LEV THE PHYSICIAN PERFORMED A COUPLE OF RESHEATHS AND REPOSITIONS (NOTHING UNUSUAL). NO PVL. DURING LEV DEPLOYMENT THE PATIENT WENT HYPOTENSIVE (100 DOWN TO 60) - AS A RESULT OF THIS ADDITIONAL INFORMATION A COMPLAINT WILL NOW BE RAISED TO ADDRESS THE HYPOTENSION FOR THE LEV. REMOVED THE LEV DEVICE AFTER VALVE DEPLOYMENT WITH NO RESISTANCE NOTED. EVERYTHING WAS FINE THE LEV. WHILE ATTEMPTING TO WITHDRAW THE LIS A DIFFICULTY WAS ENCOUNTERED. THEY PUT A DILATOR IN BUT THIS DID NOT HELP. ADMINISTERED DRUGS AS THEY THOUGHT THE PATIENT WENT INTO VASOSPASM. THE RESTRICTION WAS NOTED ABOVE THE BIFURCATION. THEY DID NOT PUT ANYTHING IN THE CONTRALATERAL SIDE. A COUPLE OF INCHES BEFORE THE LIS WAS REMOVED FROM THE BODY THEY TOOK A VIEW AND SAW THAT THE "ARTERY WAS DESTROYED". WENT IN WITH 2 OR 3 COVERED STENTS (EXTERNAL ILIAC TO COMMON ILIAC). FELT THE STENTS ADDRESSED THE BLOOD LOSS AT THE TOP OF THE STENT BUT BLOOD EXTRAVASATION IDENTIFIED AT THE BOTTOM OF THE STENTS. FELT THE BLOOD LOSS WAS PUTTING PRESSURE ON THE PATIENT'S VENA CAVA. HAD TO PERFORM CPR PRIOR TO MOVING THE PATIENT TO THE OPERATING ROOM. CASE # (B)(4). HOSPITAL WON'T RELEASE THE SHEATH UNTIL THEY PERFORM THEIR INVESTIGATION. PATIENT DIED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379098 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR200 0000012694 05391526210116

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R