BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI

    MDR report key: 6123140 · Received November 22, 2016

    Report

    Report Number
    2126666-2016-00092
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 22, 2016
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K130798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. REVIEW OF THE DIRECTIONS FOR USE NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. A COMBINATION OF PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR FAILURE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. DISPOSED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, A SAFARI WIRE REPLACED ANOTHER WIRE USED TO CROSS THE AORTIC VALVE, BALLOON VALVULOPLASTY WAS PERFORMED FOLLOWED BY THE SLOW DEPLOYED OF THE 23MM LOTUS VALVE WHICH WAS SEATED WELL WITHIN THE ANNULUS. POST DEPLOYMENT OF THE LOTUS VALVE, THE SAFARI WIRE ALONG WITH OTHER WIRES WERE REMOVED WHEN THE SUBJECT WAS NOTED TO HAVE AN ACUTE DROP IN BLOOD PRESSURE. ECHO REVEALED AN ENLARGING PERICARDIAL EFFUSION. PERICARDIAL WINDOW WAS PERFORMED THROUGH AN ABDOMINAL INCISION AND THE PERICARDIAL EFFUSION WAS EVACUATED. HOWEVER, THE BLEEDING PERSISTED AND STERNOTOMY WAS PERFORMED, THE SUBJECT WAS PLACED ON CARDIOPULMONARY BYPASS. THE HEART WAS LIFTED AND NO ACTIVE BLEEDING SITE COULD BE OBSERVED. UPON PLACING THE HEART BACK, THE BLEEDING CONTINUED. TO PERFORM FURTHER INVESTIGATION FOR AORTIC ROOT DISRUPTION THE SUBJECT WAS COOLED TO 32 DEGREE AND COLD ANTEGRADE BLOOD CARDIOPLEGIA WAS GIVEN UNTIL THE HEART ARRESTED. TRAN VERSE AORTOTOMY WAS PERFORMED, AND THE LOTUS VALVE, WHICH WAS WELL SEATED, WAS REMOVED. THE NATIVE AORTIC VALVE WAS EXCISED AND THE ANNULUS WAS DEBRIDED OF CALCIUM. A 19 MM ST JUDE'S TRIFECTA VALVE WAS THEN PLACED. AORTOTOMY WAS CLOSED. THE HEART THAN RETURNED TO NORMAL RHYTHM AND THE SUBJECT WAS SLOWLY WEANED OF CARDIOPULMONARY BYPASS. HOWEVER, AGAIN A LARGE VOLUME OF BLOOD WAS NOTED IN THE POSTERIOR AREA OF THE HEART. THE HEART WAS LIFTED AND THIS REVEALED A PERFORATION IN THE POSTERIOR WALL OF THE LEFT VENTRICLE. USING, LARGE FELT STRIPS, SUTURE, TACHOSIL, AND BIOGLUE, THE PERFORATION WAS REPAIRED. THE HEART ONCE AGAIN RETURNED TO NORMAL RHYTHM AND THE SUBJECT WAS SUCCESSFULLY WEANED OFF CARDIO PULMONARY BYPASS AND STERNUM WAS CLOSED. THE SUBJECT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. AT NIGHT, THE SUBJECT WAS NOTED TO BE COMING OF PUMP AND WAS NOTED TO HAVE A DISTENDED ABDOMEN AND WAS HYPOTENSIVE. THERE WAS NO ACTIVE BLEEDING NOTED AT THE CATHETERIZATION SITE, HOWEVER, THERE WAS A POSSIBLE RETROPERITONEAL BLEED (SITE QUERIED FOR REPORTABLE EVENT). CATHETER WAS PLACED IN THE CONTRALATERAL SIDE AND CONTRAST DYE REVEALED NO ACTIVE EXTRAVASATION. CARDIAC OUTPUT WAS MINIMAL. THE SAME DAY AS INDEX PROCEDURE, DESPITE PROLONGED CPR, THE SUBJECT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772983 PREFORM GUIDEWIRE - SAFARI WIRE GUIDE DQX LAKE REGION MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death