BEUDAMED
    FDA Adverse Event Death Summary report: N

    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    MDR report key: 2188615 · Received July 26, 2011

    Report

    Report Number
    2939520-2011-00051
    Event Type
    Death
    Date Received
    July 26, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 30, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K092596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: OTHER: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER THEREFORE THE DEVICE EVALUATION WAS NOT POSSIBLE. CARDIOLOGIST, SURGEON, AND CORONER STATEMENTS WERE REVIEWED BY MANUFACTURER'S CLINICAL AFFAIRS (CA) AND WRITTEN ASSESSMENT WAS GENERATED. EVALUATION RESULTS: THE MANUFACTURER'S (CA) ASSESSMENT STATES THAT FROM THE EVENTS RECEIVED TO DATE, IT APPEARS THAT THE PATIENT SUCCUMBED TO DEATH AS A RESULT OF CARDIAC TAMPONADE, ACUTE HEMOPERICARDIUM AND A DISSECTING ANEURYSM. IT WAS COMMENTED BY THE CLINICAL TRIAL MONITOR ON (B)(6) 2011 THAT UPON REVIEW OF THE PATIENT'S FILMS, THE PHYSICIAN FOUND OUT THAT THE PATIENT HAD A VERY SMALL TEAR IN THE STUDY VESSEL. IT WAS REPORTED THAT THE PHYSICIAN REVIEWED THE ANGIOGRAM FILMS WITH ONE OF THE CARDIAC SURGEONS. THE SURGEON SAID THE THORACIC ANEURYSM WAS A MORTAL ANEURYSM PRESENT BEFORE THE PROCEDURE AND PRIOR TO ENROLLMENT IN THE STUDY. THE DEATH CERTIFICATE PLACED THE CAUSE OF DEATH DUE TO CARDIAC TAMPONADE, ACUTE HEMOPERICARDIUM AND A DISSECTING ANEURYSM. THERE WAS NO MENTION OF ANY TEARS NOTED IN THE CORONARY ARTERY. THE MANUFACTURER'S CA ASSESSMENT STATES THAT FROM THE EVENTS RECEIVED TO DATE, IT APPEARS THAT THE PATIENT SUCCUMBED TO DEATH TO AS A RESULT OF CARDIAC TAMPONADE, ACUTE HEMOPERICARDIUM AND A DISSECTING ANEURYSM. THE FAMILY DID NOT REPORT ANY COMPLAINTS OF CHEST PAIN (ANGINA) OR OTHER DISCOMFORT FOLLOWING THE PROCEDURE. THE DEVICE WAS NOT RETURNED, AS THE EVENT HAPPENED AFTER THE PROCEDURE. BASED ON THE EVIDENCE RECEIVED TO DATE, IT DOES NOT APPEAR THE DEATH WAS NEITHER A RESULT OF THE USE OF THE MANUFACTURER'S IVUS CATHETER NOR THE RESULT OF PARTICIPATING IN THE VERDICT TRIAL. THIS IS AN UNFORTUNATE SITUATION. THE INSTITUTIONAL REVIEW BOARD (IRB) WAS NOTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IVUS CATHETER WAS USED IN (B)(4) PATIENT WHO HAD AN INTERVENTIONAL PROCEDURE WITHOUT ANY INCIDENT. THE PATIENT WAS DISCHARGED HOME. HE WAS THEN BROUGHT BACK TO THE EMERGENCY ROOM LATER THAT DAY IN FULL CARDIAC ARREST. ACCORDING TO THE HOSPITAL REPORT, THE FAMILY STATES THAT THE PATIENT WAS SITTING ON THE COUCH WHEN THE PATIENT HAD WHAT APPEARED TO BE A SEIZURE. THE FAMILY CALLED FOR EMERGENCY SERVICES AND IN A SHORT TIME THE PARAMEDICS ARRIVED TO FIND THE PATIENT LYING ON THE FLOOR UNCONSCIOUS AND WITHOUT ANY SPONTANEOUS PULSE OR RESPIRATIONS. THE PATIENT WAS INTUBATED, AND IO WAS STARTED, AND CPR/ACLS GUIDELINES WERE INITIATED AND CONTINUED DURING TRANSPORT. ON ARRIVAL THE PATIENT IS FOUND AGAIN IN A PULSELESS STATE, WITH ASYSTOLE (WITHOUT HEART BEAT) AND/OR PEA ON THE MONITOR, AND CARDIOPULMONARY RESUSCITATION (CPR) MEASURES WERE TAKEN. ATRAUMIC HEAD, FIXED AND DILATED PUPILS, AND ENDOTRACHEAL (ET) TUBE SECURED ROUGHLY 25 OR 26 CM AT THE LIPS. HEART SOUNDS WERE ABSENT. SOUNDS WERE PROMINENT ON THE RIGHT LUNGS AND GREATLY DIMINISHED ON THE LEFT. THE PATIENT SHOWED NO RESPONSIVENESS TO THE VERBAL OR PHYSICAL STIMULI, AND SHOWED NO POSTURING. CPR WAS CONTINUED AS WERE RESUSCITATION EFFORTS ACCORDING TO MOST RECENT ACLS GUIDELINES. THE ET-TUBE WAS ALSO ADJUSTED IN DEPTH ACHIEVING A FULL BILATERAL BREATH SOUNDS WITH BAGGING. ADDITIONAL EPINEPHRINE AND VASOPRESSIN, PLUS SODIUM BICARBONATE WERE ADMINISTERED THROUGH A PERIPHERAL IV, WHICH WAS ESTABLISHED UPON ARRIVAL, AND TRANSCUTANEOUS PACING WAS ALSO ATTEMPTED WITH NO CAPTURE. AT NO POINT DID THE PATIENT RECOVER A PULSE AND THE RHYTHM CONTINUED AS ASYSTOLE OR PEA. EMERGENCY ROOM HAD APPROACHED AND THEN EXCEEDED 40 MINUTES OF TOTAL RESUSCITATION EFFORTS AND WITH THE CHANCES OF RETURN OF SPONTANEOUS CIRCULATION AND SURVIVABILITY BECOMING EXCEEDINGLY LOW, EMERGENCY ROOM ABORTED EFFORTS AND PRONOUNCED THE PATIENT DEAD. THE PATIENT DIED THE SAME DAY HE WAS DISCHARGED. HE PRESENTED TO A LOCAL EMERGENCY ROOM LATER THAT DAY AND DIED WHILE IN THE EMERGENCY ROOM. THE EMERGENCY ROOM REPORT STATES CARDIAC ARREST AS CAUSE OF DEATH. AN AUTOPSY WAS PERFORMED AND INDICATED THAT CAUSE OF DEATH WERE CARDIAC TAMPONADE, ACUTE HEMOPERICARDIUM, DISSECTING AORTIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER IYO VOLCANO CORPORATION 85900P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death