BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4339979 · Received December 12, 2014

    Report

    Report Number
    3004193842-2014-00004
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    October 30, 2014
    Report Date
    December 5, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE SUBJECT WAS ENROLLED INTO THE (B)(4) STUDY ON (B)(6) 2014. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTI-COAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTI-PLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. ON (B)(6) 2014, THE SUBJECT RECEIVED A LOADING DOSE OF 324 MG OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 23 MM LOTUS VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS VALVE INVOLVED COMPLETE RESHEATHING AND THE LOTUS VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS. RETRIEVAL WAS NO ATTEMPTED. OF NOTE, INITIALLY A 23 MM LOTUS VALVE WAS OPENED AND DURING THE 'FINAL SHEATHING' OF THE VALVE PREPARATION, A 'CLICKING' NOISE WAS HEARD. AS THE LOTUS VALVE WAS USED FURTHER, ANOTHER 'CLICKING' NOISE WAS HEARD DURING RESHEATHING. HENCE, THE LOTUS VALVE WAS NOT INSERTED AND WAS EVENTUALLY REPLACED BY ANOTHER 23 MM LOTUS VALVE. AS THE LOTUS VALVE IS UNDER IDE IN USA, NO COMPLAINT HAS BEEN SUBMITTED FOR THE SAME. ISCHEMIC RIGHT LOWER EXTREMITY (001): ON (B)(6) 2014, DURING INDEX PROCEDURE, A BSC SAFARI EXTRA STIFF WIRE WAS PLACED IN APEX OF LEFT VENTRICLE AND BALLOON VALVULOPLASTY WAS PERFORMED. LOTUS INTRODUCER SHEATH WITH THE LOTUS VALVE WAS PLACED INTO THE DESCENDING THORACIC AORTA AND THE LOTUS VALVE WAS ADVANCED INTO THE STENOTIC AORTIC VALVE. DURING VALVE DEPLOYMENT, THE SUBJECT DEVELOPED HYPOTENSION AND WAS TREATED WITH ADMINISTRATION OF EPINEPHRINE AND CPR (SITE HAS BEEN QUERIED FOR REPORTABILITY OF THE EVENTS). HOWEVER, ONCE THE 23 MM LOTUS VALVE WAS IMPLANTED, THE SUBJECT'S HEMODYNAMIC STATUS IMPROVED. LOTUS VALVE WAS IMPLANTED, THE SUBJECT'S HEMODYNAMIC STATUS IMPROVED. ON (B)(6) 2014, SAME DAY OF THE INDEX PROCEDURE, POST TAVI, THD SUBJECT WAS NOTED TO HAVE RIGHT LOWER EXTREMITY ISCHEMIA. AORTOILIAC AND RIGHT FEMOROPOPLITEAL THROMBECTOMY WAS RECOMMENDED. PER EDC, POST DEVICE, IMPLANTATION, DISTAL EMBOLIZATION (NON-CEREBRAL) AND NEW IPSILATERAL ISCHEMIA WAS NOTED WHICH LEAD TO 'MAJOR VASCULAR COMPLICATION'. OF NOTE, PER EDC, INFORMATION ABOUT THE DEVICE WHICH CAUSED DISSECTION WAS NOT KNOWN. ALSO, SITE HAS CONFIRMED THAT THE SUBJECT HAD A PROLONGED AN DIFFICULT ACCESS ATTEMPT AND DEVELOPED 'ISCHEMIC LIMB AFTER CLOSURE'. ON (B)(6) 2014, THE SUBJECT UNDERWENT 'RIGHT FEMORAL CUT DOWN' WITH THROMBECTOMY OF THE RIGHT 'FEMOROPOPLITEAL' AND AORTO ILIAC ARTERY. THE SUBJECT WAS NOT TRANSFUSED AND NO HEMATOLOGICAL MEASUREMENTS WERE PERFORMED FOR THE EVENT. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED TO BE RECOVERING/RESOLVING. ON (B)(6) 2014, THE SUBJECT WAS DISCHARGED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808018 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA-TACTX MEDICAL 240063

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention