BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2103052 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03687
    Event Type
    Death
    Date Received
    May 25, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF NEUROLOGICAL DEFICIT/DYSFUNCTION AND DEATH ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, THE FOLLOWING INFORMATION WAS RECEIVED: THE IMMEDIATE CAUSE OF DEATH WAS MOST LIKELY FROM PNEUMONIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6 ) 2011, BEFORE THE CAROTID STENT PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH RIGHT SIDED WEAKNESS, GARBLED SPEECH, DYSARTHRIA, CONFUSION, RIGHT PUPIL GREATER THAN LEFT AND IN RESPIRATORY FAILURE. THE PATIENT WAS ILL-APPEARING, CACHECTIC AND IN ACUTE DISTRESS. ARTERIAL BLOOD GAS WAS PERFORMED AND THE PATIENT WAS INTUBATED. ADDITIONALLY, A CT OF THE NECK WAS DONE SHOWING THROMBUS IN THE LEFT COMMON CAROTID ARTERY (LCCA) WITH SEVERE NARROWING AT THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY (LICA). LATER THAT DAY, THE PATIENT WAS TAKEN TO THE CATHETER LAB FOR PLACEMENT OF TWO STENTS, AN RX ACCULINK STENT AND AN XACT STENT TO THE LICA. ON (B)(6) 2011, HEAD CT SHOWED HYPERPERFUSION SYNDROME. DURING A COUGHING INCIDENT, THE PATIENT SELF EXTUBATED AND WAS PLACED ON A 100% NON-REBREATHER MASK. SHORTLY AFTER, IT WAS DECIDED TO CHANGE THE STATUS TO DO NOT RESUSCITATE/DO NOT INTUBATE/COMFORT MEASURES ONLY. THE PATIENT DEVELOPED A MUCOUS PLUG, WENT INTO RESPIRATORY FAILURE AND ON (B)(6) 2011, DIED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 1022261

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death STENT: XACT 10-8X30