BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 7027328 · Received November 13, 2017

    Report

    Report Number
    MW5073277
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING HEART CATHETERIZATION, PT BECAME AGITATED AND MOVED DURING THE PROCEDURE WHICH CAUSED DISRUPTION OF THE STENT AND WAS UNABLE TO BE DISTENDED AND INADVERTENTLY WAS RELEASED. THIS REQUIRED A SECOND CATH PUNCTURE SITE IN THE RIGHT GROIN TO ALLOW FOR A SNARE TO RETRIEVE THE UNDEPLOYED STENT. DURING THE USE OF THE SNARE, THERE WAS CONCERN THAT IT MAY HAVE CAUSED DISSECTION. PT WAS INTUBATED TO PREVENT FURTHER MOVEMENT DUE TO AGITATION. PT THEN UNDERWENT A SECOND CATH ATTEMPT WITH DEPLOYMENT OF A 5MM BMS STENT TO THE OSTIUM OF THE RCA. POST PROCEDURE, THE PT WAS TRANSFERRED TO THE ICU, INTUBATED AND ON MECHANICAL VENTILATION. UPON ARRIVAL TO THE ICU, PT SUSTAINED A CARDIOPULMONARY ARREST WITH SUCCESSFUL RESUSCITATION EFFORTS. POST PROCEDURE DAY 2 ((B)(6) 2017), PT IS EXTUBATED, OOB, EATING BREAKFAST AND PENDING DISCHARGE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803140 MEDTRONIC CORONARY STENT SYSTEM NIQ MEDTRONIC 4.5MM X 15MM 0008712050

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention