BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDWIRE - SAFARI2

    MDR report key: 8903327 · Received August 16, 2019

    Report

    Report Number
    2126666-2019-00055
    Event Type
    Death
    Date Received
    August 16, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 16, 2019
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    UDI-DI
    08714729887638
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    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 MANUFACTURING BATCH LOT WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. REVIEW OF THE DIRECTIONS FOR USE NOTES THE REPORTED EVENT AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT: DURING VALVULOPLASTY THE 1ST BALLOON USED WAS RATHER UNSTABLE DURING INFLATION MOVING RAPIDLY UP/DOWN. A SECOND, BIGGER, BALLOON WAS USED AND A STABLE BAV WAS PERFORMED. DURING VALVE IMPLANTATION ON THE SECOND ATTEMPT OF POSITIONING THE VALVE TO THE AORTIC ANNULUS THE VALVE WAS POSITIONED TOO DEEP AND HAD TO BE PULLED BACK FOR ATTEMPTING AGAIN. DURING PULLING BACK THE DEVICE THE SAFARI2 GUIDEWIRE WAS ALSO PULLED OUT OF THE LEFT VENTRICLE OVER THE ANNULUS AND THE NECESSARY ACCESS TO THE LEFT VENTRICLE FOR CONTINUING THE ACCURATE NEO DEPLOYMENT WAS LOST. THUS, IT WAS DECIDED TO RELEASE THE VALVE IN THE ABDOMINAL AORTA SINCE IT WAS NOT POSSIBLE TO SAFELY WITHDRAW THE SYSTEM FROM THE PATIENT. AFTERWARDS THE PATIENT DEVELOPED A PERICARDIAC TAMPONADE WHICH WAS MITIGATED BY THE IMPLANTING TEAM AND DRAINAGE WAS INITIATED. TAVI PROCEDURE HAD TO BE ABORTED FOR THE TIME BEING. POST PROCEDURALLY PATIENT DEVELOPED AGAIN PERICARDIAL TAMPONADE WHICH WAS ATTEMPTED TO BE MITIGATED BUT ULTIMATELY SUFFERED A CARDIAC ARREST THAT WAS NOT POSSIBLE TO BE RECOVERED AND PATIENT PASSED AWAY. IT WAS REPORTED IN EMAIL THAT: AN ACCURATE NEO HAD TO BE RELEASED IN THE ABDOMINAL AORTA DUE TO LOOSING GUIDEWIRE ACCESS TO THE LEFT VENTRICLE DURING POSITIONING. ADDITIONALLY, THE PATIENT APPEARED TO HAVE PERICARDIAL TAMPONADE PERI PROCEDURALLY WHICH WAS MITIGATED. POST PROCEDURALLY PATIENT DEVELOPED AGAIN PERICARDIAL TAMPONADE AND ULTIMATELY PATIENT SUFFERED A CARDIAC ARREST AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695041 PREFORM GUIDWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL H74939407XS0 11040649 08714729887638

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death