BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4339980 · Received December 12, 2014

    Report

    Report Number
    3004193842-2014-00003
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    November 18, 2014
    Report Date
    December 1, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT IS PART OF CLINICAL STUDY (B)(4).

    Description of Event or Problem · 1

    (B)(4) ((PERICARDIAL EFFUSION WITH DECLINE IN BP TO SUGGEST HEMODYNAMIC TAMPONADE (BLEEDING COMPLICATION, PERICARDIAL EFFUSION WITH DECLINE IN BP TO SUGGEST HEMODYNAMIC TAMPONADE (CARDIAC TAMPONADE), PLAQUE DISRUPTION IN LEFT MAIN ARTERY, VALVE INTRODUCER SHEATH POKED INTO AORTIC WALL AND/OR LEFT MAIN CORONARY ARTERY)). PROCEDURE SUMMARY: THE SUBJECT WAS ENROLLED INTO (B)(4) STUDY ON (B)(6) 2014. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 27 MM LOTUS VALVE. EVENT DESCRIPTION: VALVE INTRODUCER SHEATH POKED INTO AORTIC WALL AND/OR LEFT MAIN CORONARY ARTERY/PERICARDIAL EFFUSION WITH DECLINE IN BP TO SUGGEST HEMODYNAMIC TAMPONADE (AE 001-BLEEDING EVENT) / PERICARDIAL EFFUSION WITH DECLINE IN BP TO SUGGEST HEMODYNAMIC TAMPONADE (AE 00111-CARDIAC TAMPONADE) / PLAQUE DISRUPTION IN LEFT MAIN ARTERY (AE002): ON (B)(6) 2014, DURING THE INDEX PROCEDURE, ONE OF THE VALVE INTRODUCER SHEATH RUNNERS WAS NOTED TO HAVE 'POKED INTO AORTIC WALL AND/OR LEFT MAIN CORONARY ARTERY.' ON (B)(6) 2014, ON THE SAME DAY POST INDEX PROCEDURE, CORONARY ARTERIOGRAM REVEALED PRESENCE OF 'INTIMAL FLAP OR UNROOFED PLAQUE AT THE LEFT MAIN OSTIUM' WHICH WAS TREATED BY PLACING A 4MM X 12MM XIENCE DRUG ELUTING STENT. FINAL ANGIOGRAPHY REVEALED GOOD TRACKING OF OSTIAL LEFT MAIN PLAQUE AND A POSSIBLE DISSECTION WITH 0 TO 10% RESIDUAL STENOSIS IN THE LEFT MAIN ARTERY. THE SUBJECT WAS ALSO NOTED TO HAVE PERICARDIAL EFFUSION WITH DECLINE IN BLEED PRESSURE SUGGESTIVE OF HEMODYNAMIC TAMPONADE WHICH WAS DRAINED PERCUTANEOUSLY (250 ML OF BLOOD WAS DRAINED). ON (B)(6) 2014, THE SUBJECT WAS TRANSFUSED WITH 2 UNITS OF PRBC.. HEMATOLOGY MEASUREMENTS ON (B)(6) 2014 REVEALED: LOWEST HEMOGLOBIN LEVEL ASSOCIATED WITH THE EVENT: 6.8 G/DL (NORMAL RANGE: 11.7 G/DL -15.5 G/DL). LOWEST HEMATOCRIT LEVEL ASSOCIATED WITH THE EVENT: 19/1 % (NORMAL RANGE: 35% - 45%). ON (B)(6) 2014, THE SUBJECT WAS FURTHER TRANSFUSED WITH 1 MORE UNIT OF PRBC. POST TRANSFUSION, THE SUBJECT'S HEMOGLOBIN LEVELS IMPROVED TO 7.9 G/DL. THA VARC CLASSIFICATION FOR BLEEDING EVENT: LIFE-THREATENING OR DISABLING. ON (B)(6) 2014, THE EVENT OF PLAQUE DISRUPTION IN LEFT MAIN ARTERY (AE 002) WAS CONSIDERED TO BE RESOLVED. AT THE TIME OF REPORTING THE EVENT OF 'PERICARDIAL EFFUSION WITH DECLINE IN BP TO SUGGEST HEMODYNAMIC TAMPONADE' WAS CONSIDERED TO BE RECOVERING / RESOLVING. NO OTHER INFORMATION IS CURRENTLY AVAILABLE AND SITE HAS BEEN QUERIED FOR FURTHER INFORMATION. POTENTIAL RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR (AE001), (AE0011), AND (AE002): RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808037 LOTUS INTRODUCER SET INTRODUVER CATHETER DYB CREGANNA-TACTX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R