BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 8730903 · Received June 25, 2019

    Report

    Report Number
    3004193842-2019-00007
    Event Type
    Death
    Date Received
    June 25, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP MDR REPORT IS BEING FILED VAS IT WAS CONFIRMED THAT THE LOTUS DEVICE DID NOT CAUSE THE PATIENT DEATH EARLIER REPORTED, THEREFORE THIS COMPLAINT IS NO LONGER A REPORTABLE COMPLAINT.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR REPORT IS BEING FILED VAS IT WAS CONFIRMED THAT THE LOTUS DEVICE DID NOT CAUSE THE PATIENT DEATH EARLIER REPORTED, THEREFORE THIS COMPLAINT IS NO LONGER A REPORTABLE COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO CREGANNA MEDICAL. AS THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION, IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THE PHYSICIAN CONFIRMED THAT THE PATIENT DEATH WAS NOT ASSOCIATED WITH THE LOTUS INTRODUCER. THE ISSUE REPORTED FOR THE LOTUS INTRODUCER SHEATH I.E. DIFFICULTY ADVANCING COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED TO CREGANNA FOR INVESTIGATIONS. THE COMPLAINT DETAILS WERE SENT TO CREGANNA MEDICAL ADVISOR FOR FURTHER REVIEW. THE CLINICAL REVIEWER CONFIRMED THROUGH A REVIEW OF THE INFORMATION RECEIVED FROM BSC THAT THE PATIENT DEATH WAS NOT RELATED TO THE LOTUS INTRODUCER SHEATH. THIS CONCURS WITH THE INFORMATION PROVIDED BY BSC IN THE INITIAL COMPLAINT INFORMATION RECEIVED. 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 521464 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. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. AS OF 20TH JUNE 2019, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 521464, FOR THE REPORTED ISSUES FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. THE COMPLAINT REPORTED CLASSIFICATION HAS BEEN ASSIGNED AS: PRIMARY CLASSIFICATION AS LOTUS - PATIENT - DEATH AND SECONDARY "LOTUS - INTRODUCER SHEATH - DIFFICULTY ADVANCING." THE PROBABLE INVESTIGATION CONCLUSION CODE ASSIGNED TO THIS COMPLAINT IS ' ADVERSE EVENT RELATED TO PATIENT CONDITION'. THE DEFINITION OF 'ADVERSE EVENT RELATED TO PATIENT CONDITION' IS ' AN EXISTING CONDITION OR DISEASE IS DEMONSTRABLY RESPONSIBLE FOR THE ADVERSE EVENT AND USE OF THE DEVICE HAS NEITHER CAUSED NOR OTHERWISE INFLUENCED THIS CONDITION/DISEASE-RELATED ADVERSE EVENT.' THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "ALL PRIOR TAVI PREPARATIONS DONE BY HOSPITAL PROTOCOL AND WITHOUT PROBLEMS. PUNCTURE OK. THE LOTUS INTRODUCER SHEATH (LISL) DO NOT INITIALLY GO IN WELL AS IT APPEARED TO GET STUCK TO VERY SHORT CONCENTRIC PLAQUE. THE PHYSICIANS USED 8 MM BALLOON X2 TO OPEN THE CALCIFIED AREA AND THEN WANTED TO USE A NEW LISL. THE SECOND INTRODUCER WENT IN PERFECTLY (THE FIRST ONE WAS TOTALLY NORMAL WHEN TAKEN OUT, NO KINKS OR ANY DAMAGE SEEN). OTHER NORMAL TAVI PROCEDURE PHASES WERE DONE WITH NORMAL PROTOCOL AS WELL AS PREPPING THE LOTUS VALVE. AFTER GAINING ACCESS, THE HEMODYNAMIC MEASUREMENT MONITORS ON THE LARGE SCREEN HAD A TECHNICAL PROBLEM AND STOPPED WORKING SO THE BP AND HEART RHYTHM WAS MONITORED FROM A SMALL PORTABLE SCREEN. PRE-DILATATION WAS DONE WITH A 21MM TRUE BALLOON AND AFTER THAT LOTUS EDGE 25MM TAVI DELIVERY SYSTEM (LOT 23446111) WENT IN SMOOTHLY AND PASSED THE NATIVE VALVE EASILY AND WITH NO PROBLEMS. DURING THE FIRST UNSHEATHING OF THE VALVE AND INITIAL POSITION OF THE VALVE, THE PATIENTS BP DROPPED AND HE WENT INTO VENTRICULAR DEFIBRILLATION. AFTER A SHORT CPR THE PATIENT'S HEMODYNAMICS STABILIZED AND THE DOCTORS CONTINUED WITH THE VALVE IMPLANT. DUE TO THE INITIAL TOO HIGH POSITION AND PVL, THE VALVE WAS REPOSITIONED LOWER AND LOCKED, BUT THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AGAIN. THE PERICARDIUM WAS CHECKED BY ECHO - NO TAMPONADE. THE RESUSCITATION CONTINUED FOR 26 MIN WITH NO NORMAL HEART RHYTHM OR BLOOD FLOW AND PATIENT WAS CONFIRMED DEAD. THE FINAL STAGE DEPLOYMENT OF THE VALVE IS COMPLETED (VALVE RELEASED AND DS WAS REMOVED). THE LISL WAS REMOVED AND PUNCTURE SITE WAS CLOSED WITH THE 2 PROGLIDES. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: UNRELATED. EVENT DATE: (B)(6) 2019."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524975 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR200

    Patients

    Seq Age Sex Outcome Treatment
    1 Death