BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2140111 · Received June 25, 2011

    Report

    Report Number
    2024168-2011-04484
    Event Type
    Death
    Date Received
    June 25, 2011
    Date of Event
    May 7, 2011
    Report Date
    June 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STENTS: NOBORI 3.5 X 24MM; XIENCE PRIME 2.75 X 12MM; RESOLUTE INTEGRITY 2.75 X 18MM. THE DEVICE WAS RETAINED BY THE HOSPITAL. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. IT WAS CONCLUDED THAT THE CINE IS CONSISTENT WITH THE REPORTED EVENTS. REVIEW OF THE CINE SHOWS PREDILATATION OF THE LESIONS FOLLOWED BY ONE STENT BEING IMPLANTED IN THE LEFT MAIN TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND TWO ADDITIONAL STENTS IN THE LAD. THE LEFT MAIN STENT WAS POST DILATED TWICE; THE BALLOON CATHETER REMAINED IN THE INFLATED STATE AFTER THE SECOND INFLATION. THE CINE THEN SHOWS REMOVAL ATTEMPTS OF THE BALLOON DILATATION CATHETER. THERE IS EVIDENCE OF CHEST COMPRESSIONS BEING ADMINISTERED. VISUALIZATION OF THE LEFT MAIN STENT IS POOR AND THUS FULL DEPLOYMENT OF THE STENT COULD NOT BE CONFIRMED. THE PATIENT EXPERIENCED BLOOD FLOW ISSUES AFTER THE INABILITY TO DEFLATE THE VOYAGER NC BALLOON CATHETER. RESULTS PRIOR TO THE POST-DILATATION WITH THE VOYAGER NC SHOWED AN IMPROVEMENT ANGIOGRAPHICALLY IN THE PATIENTS STATE. IT WAS REPORTED THE CATHETER WAS INFLATED SUCCESSFULLY TWO TIMES AND THERE WAS NO DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT DURING POST DILATATION OF THE STENT, THE BALLOON BECAME DAMAGED, CONTRIBUTING TO THE DIFFICULTY DEFLATING THE BALLOON AND NOTED LEAK. ADDITIONALLY, IF THE BALLOON WAS NOT COMPLETELY DEFLATED, THIS WOULD CONTRIBUTE TO THE REPORTED RESISTANCE ADVANCING AND RETRACTING THE DEVICE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR PHYSICAL RESISTANCE, DEFLATION ISSUES, LEAKS, OR DIFFICULTY REMOVING FROM THE VESSEL FOR THIS LOT. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEFLATING THE CATHETER INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. TO ENSURE THESE DIFFICULTIES ARE NOT THE RESULT OF MANUFACTURING, THE CATHETERS ARE INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE ONLINE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER BALLOON INFLATION AND DEFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL EMERGENCY ROOM IN CARDIAC SHOCK. THE LESION TO BE TREATED WAS THE LEFT ANTERIOR DESCENDING ARTERY. THERE WAS A LARGE AMOUNT OF PLAQUE LOCATED IN THE DISTAL AREA OF THE LEFT MAIN, PROXIMAL TO THE TARGET LESION. PRE-DILATATION WAS PERFORMED. A NON-ABBOTT STENT WAS DEPLOYED IN THE LEFT MAIN (LM) VESSEL. A XIENCE PRIME WAS THEN PLACED DISTALLY IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, AND A NON-ABBOTT STENT WAS PLACED IN THE DIAGONAL BRANCH. THE RESULT WAS GOOD, AND POST-DILATATION WAS PERFORMED WITH THE VOYAGER NC IN THE LEFT MAIN VESSEL, ON THE FIRST STENT IMPLANTED. THE BALLOON WAS INFLATED TWICE, UP TO 18 ATMOSPHERES, AND POST-DILATATION WAS SUFFICIENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED AFTER THE SECOND INFLATION. IT WAS NOTED THAT THE BALLOON MAY HAVE BEEN CAUGHT IN THE STENT IMPLANTED IN THE LM. ATTEMPTS WERE MADE TO ADVANCE THE BALLOON DISTALLY, BUT WERE UNSUCCESSFUL. AN ATTEMPT WAS THEN MADE TO RETRACT THE BALLOON INTO THE AORTA, SO THE BALLOON COULD BE BURST IN A CONTROLLED MANNER. DURING THIS ATTEMPT, BLOOD WAS OBSERVED TO BE LEAKING FROM THE INFLATION DEVICE; IT IS UNKNOWN IF THE BALLOON BURST. ADDITIONAL ACCESS WAS OBTAINED IN THE CONTRALATERAL COMMON FEMORAL ARTERY IN AN ATTEMPT TO REACH THE BALLOON, BUT IT WAS NOT POSSIBLE AS THERE WERE A LOT OF BLOOD CLOTS, WHICH COULD NOT BE CROSSED. DURING THE ATTEMPTS TO REMOVE THE BALLOON, THE PATIENT HAD REMAINED STABLE; HOWEVER, THE INFLATED VOYAGER BALLOON COULD NOT BE REMOVED AND THE PATIENT DIED IN THE CATH LAB. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0113061

    Patients

    Seq Age Sex Outcome Treatment
    1 Death