BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4927740 · Received July 16, 2015

    Report

    Report Number
    3004193842-2015-00018
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 6, 2015
    Manufacturer
    CREGANNA MEDICAL DEVICES
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 07/16/2015: THE PATIENT UNFORTUNATELY PASSED AWAY ON FRIDAY (B)(6). AS PER PHYSICIAN SAYINGS THE REASON FOR PATIENT'S DEATH WAS A CARDIOGENIC SHOCK IN SEVERE AF. THIS MIGHT CAME AS RESULT FROM THE ELONGATED OCCLUSION WHICH MIGHT HAVE CAUSED RENAL FAILURE AND EVENTUALLY MULTIPLE ORGANS FAILURE. DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT # 269040 DID NOT HIGHLIGHT ANY ANOMALY WHICH COULD CONTRIBUTE TO THIS REPORTED EVENT. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. ONE FURTHER COMPLAINT HAS B EEN RECEIVED SPECIFIC TO LOT NUMBER 269041. COMPLAINT LOT-PC15-030 WAS RECEIVED ON THE SAME DAY FROM THE SAME PHYSICIAN DETAILING THE SAME EVENT DESCRIPTION. ON 08/11/2015 ADDITIONAL INFORMATION WAS RECEIVED SPECIFIC TO THIS CASE. REFERENCE APPENDIX 2 WHICH INCLUDES THIS DOCUMENT TITLED 'CASE INTERVIEW' ((B)(4)). DURING UNSHEATHING THE VALVE THERE WAS A DROP ON PATIENT'S PRESSURE OBSERVED. THEY TRIED TO IMPLANT THE VALVE QUICKLY BUT THERE WERE 2 EARLY CLICKS OCCURRED BEFORE LOCKING SO THE TEAM DECIDED TO RESHEATH AND REMOVE THE VALVE AND DEAL WITH THE PRESSURE DROP. THEY WERE SUSPECTING A BLEEDING DUE TO SOME DISSECTION SOMEWHERE IN THE ANATOMY. THERE WAS NO ANNULUS RUPTURE ACCORDING TO TRANSTHORACIC ASSESSMENT. THE CONTRAST INJECTION IN ABDOMINAL AORTA SHOWED A SMALL DISSECTION IN THE LOW PART OF ABDOMINAL AORTA CLOSE TO BIFURCATION. DECISION WAS TAKEN TO SURGICALLY TREAT THE PATIENT. THE PATIENT MADE IT THROUGH SURGERY AND CURRENTLY RECOVERING ON A STABLE STATUS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION CODE ASSIGNED TO THE VESSEL DISSECTION REPORTED PER THIS COMPLAINT IS 'CAUSED BY OTHER' WHERE THE COMPLAINT INVESTIGATION INDICATES ANOTHER DEVICE CAUSED THE COMPLAINT EVENT. THE CASE INTERVIEW DETAILS THE FOLLOWING; "ABLE TO EXIT THE INTRODUCER WITH GETTING THE MARKER AROUND. BECAUSE OF THE ANGLE THAT IT IS EXITING AT, THE NOSECONE DEFLECTS AND OPENS THE CATHETER TIP TO THE ANATOMY. THIS LIKELY CAUSED THE PERF." THE EVENT DESCRIPTION DETAILS THAT THE LOTUS LARGE SHEATH WAS SUCCESSFULLY INSERTED. POST INSERTION OF THE LARGE SHEATH RESISTANCE WAS OBSERVED DURING CATHETER ADVANCEMENT. BASED ON THE ABOVE IT IS PROBABLE THAT THE PERFORATION/DISSECTION WAS CAUSED BY INSERTION OF THE CATHETER POST PLACEMENT OF THE INTRODUCER SHEATH. THE ROOT CAUSE OF THE PATIENT'S DEATH IS UNDETERMINABLE WHERE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE. AN INDEPENDENT PHYSICIAN REVIEW OF THIS COMPLAINT WAS RECEIVED WITH RESPECT TO BOTH THE VESSEL DISSECTION AND THE PATIENT DEATH. WHEN ASKED IF THERE IS LIKELY TO BE A LINK BETWEEN THE VESSEL DISSECTION / LOTUS INTRODUCER DEVICE AND THE PATIENT DEATH, DR. (B)(6) STATED THE FOLLOWING; 'IT'S HARD TO BE CERTAIN, BASED ON THE DESCRIPTION THEY GIVE. I WOULD NOT EXPECT THE BLOOD PRESSURE TO DROP BECAUSE OF A DISSECTION. IT'S POSSIBLE THAT THE SURGERY IN AN ALREADY FRAIL PATIENT LED TO MULTI ORGAN FAILURE AND EVENTUAL DEATH'. THE EVENT DESCRIPTION DESCRIBES TORTUOUS PERIPHERAL ANATOMY WHICH MAY EXPLAIN THE RESISTANCE OBSERVED DURING CATHETER ADVANCEMENT. BASED ON A REVIEW OF THE FMEAS, VESSEL DISSECTION AS A REPORTED CLASSIFICATION IS NOT A NEW OR UNANTICIPATED FAILURE MODE. NO UPDATES ARE REQUIRED FOR RISK DOCUMENTATION BASED ON THIS COMPLAINT. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. THIS IS CONSIDERED THE FINAL REPORT. OTHER DEVICES USE: LOTUS SHEATH: LIS-L LOT: 269041 (X2). SAFARI WIRE: H74939272S1 LOT: 10528166 (X3).

    Description of Event or Problem · 1

    PATIENT APPROVED FOR LOTUS IMPLANTATION. TORTUOUS PERIPHERAL ANATOMY BUT WITH BIG ENOUGH DIAMETERS ON BOTH SIDES TO ACCOMMODATE THE LARGE SHEATH. LEFT SIDE ACCESS DECIDED. LOTUS LARGE SHEATH WAS SUCCESSFULLY INSERTED AND VALVE WAS PREPARED AND GIVEN FOR INSERTION. AFTER A WHILE OF CATHETER ADVANCEMENT (STILL ON ILIAC), THE FIRST OPERATOR EXPERIENCED RESISTANCE AND AS WE SAW ON THE SCREEN IT WAS ON THE POSITION OF A CURVE OF THE ILIAC VESSEL. DECISION WAS TAKEN TO STOP, REMOVE THE CATHETER AND CHANGE THE SAFARI WIRE AND TRY TO STRAIGHTEN THE SHEATH BY PARTIALLY REMOVING AND READVANCING IT WITH ITS DILATOR. VALVE WAS KEPT UNDERWATER AND STILL SHEATHED WITHOUT ANY OBVIOUS DAMAGE. THEY TRIED AGAIN WITH THE SAME RESULTS. THEY AGAIN TOOK THE CATHETER OUT. FOR THE THIRD TIME THEY CHANGED THE SHEATH AND SAFARI WIRE (3RD ONE). FOR THIS TIME, THE VALVE WAS UNSHEATHED, CAREFULLY INSPECTED, FLUSHED AND RE-SHEATHED AGAIN SUCCESSFULLY AND WITHOUT ANY DAMAGE. THEY MANAGED TO ADVANCE THE CATHETER THROUGH THE SHEATH AND THE ANATOMY AND STARTED TO IMPLANT THE VALVE. DURING UNSHEATHING THE VALVE THERE WAS A DROP ON THE PATIENT'S PRESSURE OBSERVED. THEY TRIED TO IMPLANT THE VALVE QUICKLY BUT THERE WERE 2 EARLY CLICKS OCCURRED BEFORE LOCKING SO THE TEAM DECIDED TO RESHEATH AND REMOVE THE VALVE AND DEAL WITH THE PRESSURE DROP. THEY WERE SUSPECTING A BLEEDING DUE TO SOME DISSECTION SOMEWHERE IN THE ANATOMY. THERE WAS NO ANNULUS RUPTURE ACCORDING TO TRANSTHORACIC ASSESSMENT. THE CONTRAST INJECTION IN ABDOMINAL AORTA SHOWED A SMALL DISSECTION IN THE LOW PART OF THE ABDOMINAL AORTA CLOSE TO BIFURCATION. DECISION WAS TAKEN TO SURGICALLY TREAT THE PATIENT. THE PATIENT MADE IT THROUGH SURGERY AND CURRENTLY RECOVERING ON A STABLE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463514 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL DEVICES NTR200 269041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R SAFARI WIRE: H74939272S1 LOT: 10528166 (X3)