BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 1695085 · Received May 18, 2010

    Report

    Report Number
    2183460-2010-00006
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    March 26, 2009
    Report Date
    May 18, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL / POSSIS
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A PT DEATH APPROX 8-12 HOURS POST ANGIOJET TREATMENT FOR A THROMBOSED DIALYSIS GRAFT. THE PT WAS A (B) (6) DIABETIC FEMALE WHO WAS UNDERGOING WEEKLY DIALYSIS TREATMENTS. THERE IS NO MORE INFO REGARDING THE PT'S MEDICAL HISTORY. NOTE: THIS EVENT OCCURRED 13 MONTHS AGO AND IS NOW BEING REPORTED DUE TO THE ATTENDING PHYSICIAN'S NOTIFICATION TO MEDRAD INTERVENTIONAL/POSSIS THAT HE IS NOW UNSURE IF THE ANGIOJET SYSTEM CONTRIBUTED TO THE PT'S DEATH. WHEN THIS EVENT FIRST OCCURRED APPROX 13 MONTHS AGO, THE ATTENDING PHYSICIAN INFORMED THE SALES REP THAT HE BELIEVED THE RESPIRATORY ARREST AND PT DEATH WAS CAUSED BY AN ACUTE ALLERGIC REACTION TO THE CONTRAST MEDIA. ON A RECENT TRIP TO (B) (6) WITH THE SALES REP, THE PHYSICIAN STATED THAT HE IS NOW UNSURE IF THE BRADYARRHYTHMIAS THAT OCCURRED DURING THE ANGIOJET TREATMENT IN THE CASE MAY HAVE POSSIBLY CONTRIBUTED TO THE PT'S RESPIRATORY ARREST AND DEATH. THE PHYSICIAN WAS A NEW USER OF ANGIOJET AT THAT TIME OF THIS EVENT. SINCE THIS EARLY CASE, THE PHYSICIAN HAS USED THE ANGIOJET SYSTEM MORE AND HAS EXPERIENCED OCCASIONAL EPISODES OF BRADYCARDIA ARRHYTHMIAS. THE SALES REP STATED THAT IN HIS RECENT CONVERSATIONS WITH THE PHYSICIAN HE HAS LEARNED THAT THE PT HAD TWO BRADYARRHYTHMIAS EPISODES DURING THE ANGIOJET TREATMENT AND THEN COMPLETELY RECOVERED ONCE THE ANGIOJET TREATMENT WAS TEMPORARILY SUSPENDED. HE ALSO STATED THAT DURING A BRADYARRHYTHMIAS EPISODE, THE PT CONTINUED TO BRADY DOWN (HEART RATE CONTINUED TO DECREASE) AND THEN WENT INTO RESPIRATORY ARREST. THE PT RECOVERED AND WAS TREATED WITH BENADRYL AND OTHER DRUGS. FOLLOWING THE PROCEDURE, THE PT WAS MOVED FROM THE CATH LAB TO THE HOSPITAL. THE CATH LAB IS APPROX 20 YARDS FROM THE HOSPITAL. ON TRANSFER TO THE HOSPITAL, THE PT WAS ALERT AND RESPONSIVE, HOWEVER, APPROX 8-12 HOURS AFTER BEING TRANSFERRED TO THE HOSPITAL, THE PT UNEXPECTEDLY EXPIRED. THE PHYSICIAN BELIEVES THE PT WAS VERY SICK DUE TO THEIR UNDERLYING CONDITION AND IS NOT SURE WHAT CAME FIRST - THE BRADYARRHYTHMIAS FROM ANGIOJET THERAPY OR AN ALLERGIC REACTION TO THE CONTRAST MEDIA. THE PHYSICIAN IS NOW RELUCTANT TO TALK ABOUT THIS CASE BUT FEELS THAT THE BRADYARRHYTHMIA EVENTS MAY HAVE CONTRIBUTED TO UNK CHAIN OF EVENTS WHICH LED TO THE PT'S DEATH. THE PHYSICIAN DID NOT BELIEVE THE PT EMBOLIZED ANY THROMBUS. THE SALES REP DID NOT BELIEVE THE PT HAD UNDERGONE AN AUTOPSY. A REVIEW OF THE MEDRAD COMPLAINT SYSTEM FOR MDR EVENTS FOR DEATHS DIRECTLY RELATED TO BRADYARRHYTHMIAS REVEALED NO SUCH EVENTS. THE IFU WARNS "CARDIAC ARRHYTHMIAS DURING CATHETER OPERATION HAVE BEEN REPORTED IN A SMALL NUMBER OF PTS. CARDIAC RHYTHM SHOULD BE MONITORED DURING CATHETER USE AND APPROPRIATE MANAGEMENT, SUCH AS TEMPORARY PACING, BE EMPLOYED IF NEEDED." HANDBOOKS IN RADIOLOGY - (B) (6) AND ANGIOGRAPHY BY (B) (6) STATES "IDIOSYNCRATIC OR HYPERSENSITIVITY REACTIONS TO IODINATED CONTRAST MEDIA ARE UNPREDICTABLE AND VARY FROM SNEEZING, NAUSEA AND VOMITING, OR URTICARIA, TO LARYNGEAL EDEMA, CARDIOVASCULAR COLLAPSE, AND DEATH". AT THIS TIME, THE UNDERLYING CAUSE OF THE PT'S DEATH (WHICH OCCURRED 8-12 HOURS POST ANGIOJET TREATMENT) AND ITS RELATEDNESS TO THE ANGIOJET TREATMENT IS INCONCLUSIVE. HOWEVER, THE CAUSE OF THIS PT'S DEATH AS POSSIBLE RELATED TO ANGIOJET TREATMENT CANNOT BE CONCLUSIVELY RULED OUT AND THUS, THIS EVENT IS CONSIDERED REPORTABLE.

    Description of Event or Problem · 1

    [PER PHYSICIAN DR. (B) (6)] CARDIOPULMONARY ARREST - MOST PROBABLY SECONDARY TO CONTRAST ALLERGY. WHEN THIS EVENT OCCURRED, DR.(B) (6) TOLD ME HE BELIEVED CONDITION WAS CAUSED BY ACUTE ALLERGY. ON OUR TRIP TO (B) (4), HE SAID NOW HE THINKS THE BRADYARRYTHMIA DURING THE CASE MAY HAVE CAUSED THE PT TO CODE. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER EMBOLECTOMY CATHETER MCW MEDRAD INTERVENTIONAL / POSSIS 104529-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death