BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS¿ SR PRO

    MDR report key: 2831476 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06875
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: PATIENT SEX, RELEVANT TESTS/LAB DATA; OTHER RELEVANT HISTORY. UPDATED/CORRECTION: DESCRIBE EVENT OR PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-07357. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND DIAGNOSIS (IVUS) PROCEDURE, CATHETER PULL BACK DIFFICULTIES OCCURRED AND THROMBUS FORMED IN THE TARGET VESSEL. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE OSTIAL LEFT CIRCUMFLEX ARTERY (LCX). INITIALLY THE ILAB CART MOTORDRIVE AND THE ATLANTIS SR PRO IMAGING CATHETER FAILED TO PERFORM AN AUTOMATIC PULLPACK, BUT SUCCESSFULLY DID IT ON A THIRD ATTEMPT. AT THAT TIME THROMBUS WAS FOUND IN THE TARGET VESSEL, WHICH WAS SUCCESSFULLY EXTRACTED BY AN ASPIRATION CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE DRUG THERAPY USED DURING THE PROCEDURE WAS UNKNOWN. THE PHYSICIAN FELT THE EVENT IS CONSIDERED AS LIKELY TO BE RELATED TO THE ATLANTIS IMAGING CATHETER AND NOT THE ILAB PULLBACK FAILURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED WITH AN EPISODE OF CENTRAL CHEST DISCOMFORT. THE PATIENT DEVELOPED INFEROLATERAL ST SEGMENT DEPRESSION WITH NO SYMPTOMS. CARDIAC CATHETERIZATION WAS THEREFORE RECOMMENDED. INTRAVASCULAR ULTRASOUND CONFIRMED THAT THE MID LAD DISEASE WAS SIGNIFICANT, AND THE OSTIAL DISEASE WAS ALSO SEVERE WITH A VERY HEAVY PLAQUE BURDEN EXTENDING RIGHT BACK TO THE LEFT MAIN STEM. ANGIOGRAPHY REVEALED A FILLING DEFECT IN THE MID LAD ASSUMED TO BE A THROMBUS. HEPARIN 3,000 UNITS OVER AND ABOVE THE ORIGINAL 7,000 UNITS WAS GIVEN ALTHOUGH AN ACT CAME BACK AT 240. ABCIXIMAB WAS GIVEN AS A BOLUS AND INFUSION AND THREE EXPORT RUNS WERE UNDERTAKEN TO ASPIRATE THE CLOT. AT THE END OF THESE PROCEDURES THE LAD LOOKED SATISFACTORY WITH NO OBVIOUS THROMBUS. THE PATIENT WAS COMPLETELY ASYMPOMATIC AND WAS TRANSFERRED BACK TO CCU. AT THIS STAGE THE PATIENT WAS RECOMMENDED FOR CORONARY ARTERY BYPASS GRAFTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS¿ SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749389420 15349202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ILAB CART, MDU