BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRUITT INAHARA SHUNT

    MDR report key: 1221624 · Received October 30, 2008

    Report

    Report Number
    1220948-2008-00009
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 15, 2008
    Report Date
    January 30, 2008
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    NIM
    PMA / PMN Number
    K960715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN INFLATED THE INTERNAL CAROTID BALLOON TO THE APPROPRIATE INFLATION VOLUME. ONCE THE PROCEDURE WAS UNDERWAY, THE SAFETY BALLOON HAS INFLATED THAT ALLOWED THE INTERNAL BALLOON TO DEFLATE WITHIN THE VESSEL. THE PT SUFFERED A STROKE WHICH MAY HAVE BEEN CAUSED BY THIS INCIDENT BUT REMAINS INCONCLUSIVE. THE DOCTOR STATEMENT: "DURING THE OPERATION, THE CAROTID SHUNT SLIPPED OUT OF THE INTERNAL CAROTID ARTERY ON AT LEAST TWO OCCASIONS DURING THE OPERATION, NECESSITATING A CHANGE OF SHUNT. THE PT ALSO SUFFERED A DROP IN BLOOD PRESSURE FOR A SHORT TIME ASSOCIATED WITH ELECTRO-MECHANICAL DISSOCIATION, REQUIRING EXTERNAL CARDIAC MASSAGE FOR SEVERAL MINS. I DO NOT THINK THAT THIS LATTER EVENT WAS ASSOCIATED WITH THE SHUNT USAGE. HOWEVER, UPON RECOVERY THE PT WAS NOTED TO HAVE SUFFERED A MAJOR STROKE AFFECTING THE IPSILATERAL CAROTID CIRCULATION, THIS UNDESIRED ENDPOINT MAY OR MAY NOT HAVE BEEN ASSOCIATED WITH THE NEED TO REPEATEDLY CANNULATE THE INTERNAL CAROTID ARTERY DURING THE OPERATION. IT REMAINS UNK WHETHER THE PHYSICIAN USED THE SAFETY SLEEVE MECHANISM DURING THE PROCEDURE. THE SAFETY BALLOON IS TO BE UNCOVERED BY THE SLEEVE TO LIMIT BALLOON OVER- INFLATION AND THE POSSIBILITY OF VESSEL DAMAGE. ONCE THE INTERNAL CAROTID BALLOON HAS BEEN INFLATED TO THE DESIRED PRESSURE THE SAFETY BALLOON MUST BE COVERED BY THE SLEEVE TO PREVENT THE SAFETY BALLOON FROM DEFLATING AS SEEN WITHIN THIS INCIDENT, AS STATED WITHIN THE IFU. THE DEVICE WAS EVALUATED FOR THE REPORTED COMPLAINT AND THERE WERE NO NONCONFORMITIES FOUND WITHIN THE DEVICE. IT WAS ALSO NOTED THAT THE SAFETY BALLOON WAS RETURNED UNCOVERED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE IT IS DETERMINED WHETHER OR NOT THE PHYSICIAN USED THE SAFETY BALLOON SLEEVE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN INFLATED THE INTERNAL CAROTID BALLOON TO THE APPROPRIATE INFLATION VOLUME. ONCE THE PROCEDURE WAS UNDERWAY, THE SAFETY BALLOON HAS INFLATED THAT ALLOWED THE INTERNAL BALLOON TO DEFLATE WITHIN THE VESSEL. THE PT SUFFERED A STROKE. ROOT CAUSE OF STROKE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT INAHARA SHUNT PRUITT SHUNT NIM LEMAITRE VASCULAR 2000-49 PIS1537

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other