BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS SD BILIARY STENT SYSTEM

    MDR report key: 1781405 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03322
    Event Type
    Death
    Date Received
    August 3, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESPONSE: MODEL/CATALOG NUMBER 37912-61815 WAS PROVIDED ON THE INITIAL E-MDR SUBMITTED ON 08/05/2010. RESPONSE: LOT NUMBER 12556157 WAS PROVIDED ON THE INITIAL E-MDR SUBMITTED ON 08/05/2010. A MORE COMPLETE DESCRIPTION OF THE INCIDENT DESCRIBED IN THE MEDICAL DEVICE REPORT INCLUDING RELEVANT EVENTS PRIOR TO AND SUBSEQUENT TO THE ACTUAL INCIDENT. THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORT(S) INCLUDING: A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED, AN IDENTIFICATION OF THE FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED COMPONENT(S) INVOLVED, ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. 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 MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE USER RELATED AS THE DEVICE IS NOT INDICATED FOR USE IN THE RIGHT CORONARY ARTERY. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).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 MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE USER RELATED AS THE DEVICE IN NOT INDICATED FOR USE IN THE RIGHT CORONARY ARTERY.(B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFG. REPORT #: 2134265-2010-03323. USER FACILITY MEDWATCH REPORT (B)(4). IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A VESSEL PERFORATION OCCURRED AND THE PATIENT DIED. THE PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM TO THE CATHETERIZATION LAB AND PRESENTED WITH AN EVOLVING MYOCARDIAL INFARCTION. THE MID RIGHT CORONARY ARTERY WAS TOTALLY OCCLUDED. A GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND AN UNKNOWN BALLOON WAS USED TO OPEN THE BLOCKAGE. NEXT, AN INTRAMUSCULAR ULTRASOUND WAS ADVANCED, AND IT WAS NOTED THAT A FRESH CLOT WAS OCCLUDING THE VESSEL. THIS DEVICE WAS ALSO USED TO SIZE THE VESSEL. A FETCH CATHETER WAS USED TO EXTRACT THE CLOT. THE PHYSICIAN DEPLOYED A 6.0MM X 18MM EXPRESS SD BILIARY STENT INTO THE INTENDED LOCATION. NEXT, A SECOND 6.0MM X 18MM EXPRESS SD BILIARY STENT WAS ADVANCED. AS THE SECOND STENT EXPANDED DURING DEPLOYMENT, A VESSEL PERFORATION OCCURRED. AN UNKNOWN BALLOON WAS INFLATED AT THE PERFORATION SITE TO TRY AND TAMPONADE THE VESSEL. ONCE THE BALLOON WAS DEFLATED THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. AT THAT POINT PREPARATIONS AND ATTEMPTS WERE MADE TO REMOVE THE FLUID FROM AROUND THE PERICARDIUM, HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS INTUBATED. ECHO ASSISTANCE WAS UNSUCCESSFUL IN OBTAINING ACCESS. A CARDIAC SURGEON WAS CALLED IN TO MAKE A PERICARDIAL WINDOW. THE PATIENT CODED SEVERAL TIMES PRIOR TO THE WINDOW AND THE PATIENT RESPONDED EACH TIME TO CARDIOVERSION. AFTER THE DRAIN WAS PLACED AND SHORTLY AFTER THE FIRST EPISODE OF ASYSTOLE, THE PATIENT UNDERWENT VIGOROUS UNSUCCESSFUL RESUSCITATION EFFORTS.

    Description of Event or Problem · 1

    SAME CASE AS MFG. REPORT #: 2134265-2010-03323. USER FACILITY MEDWATCH REPORT #: (B)(4). IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A VESSEL PERFORATION OCCURRED AND THE PATIENT DIED. THE PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM TO THE CATHETERIZATION LAB AND PRESENTED WITH AN EVOLVING MYOCARDIAL INFARCTION. THE MID RIGHT CORONARY ARTERY WAS TOTALLY OCCLUDED. A GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND AN UNKNOWN BALLOON WAS USED TO OPEN THE BLOCKAGE. NEXT, AN INTRAMUSCULAR ULTRASOUND WAS ADVANCED AND IT WAS NOTED THAT A FRESH CLOT WAS OCCLUDING THE VESSEL. THIS DEVICE WAS ALSO USED TO SIZE THE VESSEL. A FETCH CATHETER WAS USED TO EXTRACT THE CLOT. THE PHYSICIAN DEPLOYED A 6.0MM X 18MM EXPRESS SD BILIARY STENT INTO THE INTENDED LOCATION. NEXT, A SECOND 6.0MM X 18MM EXPRESS SD BILIARY STENT WAS ADVANCED. AS THE SECOND STENT EXPANDED DURING DEPLOYMENT, A VESSEL PERFORATION OCCURRED. AN UNKNOWN BALLOON WAS INFLATED AT THE PERFORATION SITE TO TRY AND TAMPONADE THE VESSEL. ONCE THE BALLOON WAS DEFLATED THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. AT THAT POINT PREPARATIONS AND ATTEMPTS WERE MADE TO REMOVE THE FLUID FROM AROUND THE PERICARDIUM, HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS INTUBATED. ECHO ASSISTANCE WAS UNSUCCESSFUL IN OBTAINING ACCESS. A CARDIAC SURGEON WAS CALLED IN TO MAKE A PERICARDIAL WINDOW. THE PATIENT CODED SEVERAL TIMES PRIOR TO THE WINDOW AND THE PATIENT RESPONDED EACH TIME TO CARDIOVERSION. AFTER THE DRAIN WAS PLACED AND SHORTLY AFTER THE FIRST EPISODE OF ASYSTOLE, THE PATIENT UNDERWENT VIGOROUS UNSUCCESSFUL RESUSCITATION EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS SD BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912618150 12556157

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R EXP SD RENAL BILIARY STENT 6.0X18X150CM