BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 578040 · Received March 2, 2005

    Report

    Report Number
    2024168-2005-00106
    Event Type
    Death
    Date Received
    March 2, 2005
    Date of Event
    January 13, 2005
    Report Date
    February 9, 2005
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENED "HYPERPERFUSION SYNDROME". IN 2005, THE PT DIED, FOUR DAYS POST-OP. IT IS UNK IF THE PT'S DEATH WAS PRODUCT RELATED. INFO ALSO RECEIVED STATED THAT "NO EVIDENCE OF BLEED OR STROKE FROM CT, MRI AND NEUROLOGICAL EVAL. ALL INDICATIONS CONSISTENT WITH HYPERFUSION SYNDROME. NO ADDITIONAL INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    ADD'L INFO REPORTED THAT THE PT HAD TRANSIENT BRADYCARDIA DURING PROCEDURE; TREATED WITH ATROPINE. AFTER STENT DEPLOYMENT, PT WAS CONFUSED AND DID NOT RESPOND TO QUESTIONS. EEG WAS ABNORMAL; CT, MRI, AND MR ANGIOGRAM SHOWED INFARCTION (SMALL VESSEL EMBOLIZATION ) IN TERRITORY OF LEFT MIDDLE CEREBRAL ARTERY. ALTHOUGH SITUATION WAS FAIRLY STABLE, PT DECIDED TO INITIATE A DO NOT RESUSCITATE (DNR) STATUS SINCE THEY DID NOT WANT TO PERSIST IN A HEMIPLEGIC CONDITION. SITE REPORTED EVENT AS "HYPERPERFUSION SYNDROME", HOWEVER, FINAL DIAGNOSIS IS MAJOR, ISCHEMIC, IPSILATERAL STROKE. PT DIED IN 2005. CAUSE OF DEATH IS LISTED AS SUDDEN CARDIAC DEATH, STATUS POST CEREBROVASCULAR ACCIDENT, POST CAROTID STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H RX ACCUNET