BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1665663 · Received April 20, 2010

    Report

    Report Number
    3004742046-2010-00160
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). BASED ON THE XACT IFU, CVA, DEATH AND RESPIRATORY DISTRESS ARE KNOWN POTENTIAL ADVERSE OUTCOMES ASSOCIATED WITH CAROTIDS STENTS. IN THIS CASE, THE PRODUCT WAS NOT RETURNED FOR EVAL, WHICH MAY HAVE AIDED IN DETERMINATION OF CAUSE. ALSO, NO ANOMALIES TO THE CATHETER REPORTED DURING DELIVERY SYSTEM INSPECTION PRIOR TO USE. BASED ON THE AVAILABLE INFO AND RELEVANT MANUFACTURING RECORDS, THE INCIDENT DOES NOT APPEAR TO BE RELATED TO A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE WAS NOT IDENTIFIED, IT IS POSSIBLE THAT PT DISEASE STATE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESPIRATORY DISTRESS, DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS PRIOR TO THIS PROCEDURE, THE PT ATTEMPTED TO HAVE CAROTID STENTING; HOWEVER, DUE TO SEVERE LUNG DISEASE, WAS UNABLE TO LAY FLAT ON THE GURNEY. THE PROCEDURE WAS STARTED, BUT STOPPED PRIOR TO ANY DEVICES ENTERING THE ANATOMY DUE TO A SEVERE COUGHING ATTACK THAT RESULTED IN HOSPITAL ADMISSION AND INTUBATION. THE PT RETURNED TO BASELINE AND RETURNED FOR A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, PRESENTING WITH DYSPNEA. DURING THE PROCEDURE, THE PT STARTED COUGHING, BECAME HYPERTENSIVE AND WENT INTO RESPIRATORY DISTRESS. TREATMENT INCLUDED LASIX, ALBUTEROL AND A NITROGLYCERIN DRIP. POST-PROCEDURE, THE PT WAS LETHARGIC AND WAS NOT FOLLOWING COMMANDS, WAS INTUBATED AND A NASAL-GASTRIC TUBE WAS PLACED. A STROKE WAS DIAGNOSED AND SYMPTOMS INCLUDED LEFT SIDED PARALYSIS, HEMIANOPIA AND INATTENTIVENESS. THE PT CONTINUED TO DECLINE AND 6 DAYS POST-PROCEDURE, ON (B) (6) 2010, THE PT DIED. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9120151

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R| S HEPARIN| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| (22438-19, LOT# 0011851)