BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 7037591 · Received November 16, 2017

    Report

    Report Number
    2126666-2017-00118
    Event Type
    Death
    Date Received
    November 16, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 16, 2017
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. IT WAS REPORTED THAT THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. LOT TRACEABILITY WAS PROVIDED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND INSPECTION SPECIFICATIONS. A COMBINATION OF PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE DIRECTIONS FOR USE NOTES THE REPORTED EVENT AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. SHOULD ADDITIONAL INFORMATION BE PROVIDED OR THE DEVICE RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED: THE PATIENT WAS HAVING A TAVI PERFORMED (EVOLUTE R 29MM BY MEDTRONIC), SHE WAS AN ELDERLY LADY, SMALL IN STATURE. EF WAS 73% . SAFARI 2 SMALL CURVE WAS USED. THIS WAS INTRODUCED INTO THE PATIENT WITH NO EVENT. THE VALVE WAS FED OTW AND INTO THE LEFT VENTRICLE. THE PATIENT THEN HAD NO CARDIAC OUTPUT. CPR WAS COMMENCED AND IT WAS DECIDED TO DEPLOY THE VALVE ANYWAY. THE VALVE DELIVERY SYSTEM WAS REMOVED, AND STILL NO CARDIAC OUTPUT. THEY REMOVED THE WIRE AND CARDIAC OUTPUT RETURNED. BP PRESSURE WAS OVER 200MM HG DUE TO THE ADRENALIN GIVEN. THE PATIENT HAS REMAINED IN ICU INTUBATED AND OUTLOOK DOES NOT LOOK POSITIVE. ADDITIONAL INFORMATION RECEIVED: 11/02/2017 - UNFORTUNATELY THEY TURNED OFF THE VENTILATOR ON THE WEEKEND AND SHE PASSED AWAY. THE PROCTOR ON THE CASE BASICALLY SAID THAT DUE TO INEXPERIENCE THE PHYSICIANS PLACED THE WIRE AND IT WAS CAUGHT UP IN THE MITRAL VALVE APPARATUS. THIS CAN HAPPEN WITH WIRES, AND HE HAS SEEN IT BEFORE WITH OTHER WIRES. WHEN YOU ARE EXPERIENCED AND REALISE WHAT IT IS YOU PULL THE WIRE OUT AND REINSERT. UNFORTUNATELY DUE TO THE SERIOUS OF THE SITUATION AND THE DOCTORS TRYING TO DEPLOY THE VALVE THEY DIDN'T REALISE THIS AND THAT IS WHY THE CARDIAC OUTPUT RETURNED WHEN THE WIRE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED 11/03/2017 - WHAT WAS THE OFFICIAL CAUSE OF DEATH? THEY TURNED OFF THE VENTILATOR. HER KIDNEYS HAD SHUT DOWN AND WERE NOT GOING TO IMPROVE. DID THE PATIENT INITIALLY PRESENT EMERGENTLY FOR THE TAVI PROCEDURE OR WAS IT A PLANNED PROCEDURE? IT WAS A PLANNED PROCEDURE. THE PROCTOR INDICATED SHE WAS NOT THE "BEST CANDIDATE" . THE COMPLAINT FILE SUGGESTS THE WIRE WON'T BE RETURNED BECAUSE IT'S "CONTAMINATED". WAS THE WIRE RETAINED AT THE FACILITY OR DISPOSED? DISPOSED OF AND WON'T BE RETURNED. THE WIRE LOOKED NORMAL IN INSPECTION BY THE PROCTOR, IT WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818501 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL H74939406XS1 10812019

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death