BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3103155 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03486
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    May 5, 2011
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2011-01929, 2134265-2013-03485. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH PROGRESSIVE ANGINA AND WAS TURNED DOWN FOR BYPASS SURGERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. A 6FR RUNWAY GUIDE CATHETER AND IQ GUIDE WIRE WERE POSITIONED IN THE RIGHT CORONARY ARTERY. A 2.5X15MM APEX WAS PLACED IN THE RCA AND INFLATION WAS PERFORMED TWICE TO 14ATMS FOR 25SEC AND 11SEC. A 2.75X24MM TAXUS LIBERTE STENT WAS THEN DEPLOYED IN THE MID RCA AT 14ATMS FOR 29SEC. AS MODERATE STENOSIS WAS IDENTIFIED IN THE PROXIMAL RCA, A 3.0X12MM TAXUS LIBERTE WAS THEN DEPLOYED AT 12ATMS FOR 27SEC. THERE WAS NO RESIDUAL STENOSIS IN THE STENTED AREA. THE DEVICES WERE REMOVED. THE SECOND, 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS CIRCUMFLEX ARTERY. THE IQ GUIDE WIRE WAS PLACED IN THE CIRCUMFLEX ARTERY AND PRE-DILATION WAS PERFORMED WITH THE 2.5X15MM APEX BALLOON TO 12ATMS/15SEC. THE 2.5X18MM PROMUS WAS THEN ADVANCED OVER THE IQ GUIDE WIRE AND WAS UNABLE TO CROSS THE LESION. THE PROMUS STENT WAS REMOVED, THE IQ GUIDE WIRE WAS REMOVED AND THE 182CM PT GRAPHIX GUIDE WIRE WAS THEN ADVANCED TO THE LESION WITH DIFFICULTY NOTED. THE 2.5X18 PROMUS WAS THEN ADVANCED OVER THE PT GRAPHIX WIRE AND DEPLOYED AT 10ATMS/18SEC IN THE PROXIMAL CX, JUST DISTAL TO THE FIRST MARGINAL OR INTERMEDIATE BRANCH. THERE WAS NO RESIDUAL STENOSIS. WHILE REMOVING THE PROMUS STENT DELIVERY SYSTEM, THE GUIDE WIRE PULLED BACK INTO THE GUIDE CATHETER. FURTHER DILATION WAS PLANNED AS THERE WAS CONCERN THE PROXIMAL END OF THE STENT WAS NOT FULLY DEPLOYED AGAINST THE VESSEL WALL. A 3.0X8.0MM NC QUANTUM APEX WAS ADVANCED OVER THE PT GRAPHIX WIRE AND THEN BOTH DEVICES WERE REMOVED FOR AN UNSPECIFIED REASON. THE PT GRAPHIX WIRE WAS ADVANCED AND THEN REMOVED FOR RESHAPING. THE WIRE WAS ADVANCED AGAIN AND WHILE TRYING TO ADVANCE THE WIRE THROUGH THE STENT, IT BECAME TRAPPED UNDERNEATH THE STRUT OF THE STENT. THE 2.5X15MM APEX BALLOON WAS THEN ADVANCED TO AID IN REMOVAL. AS THE PHYSICIAN PULLED TO REMOVE THE WIRE, THE WIRE TIP DETACHED. NO ATTEMPT WAS MADE TO REMOVE THE WIRE TIP AND IT REMAINED STUCK UNDER THE STENT AT PROCEDURE END. FLOW REMAINED EXCELLENT AND THE PATIENT HAD NO SYMPTOMS. AFTER THE PATIENT WAS DISCHARGED TO HOME, THE PHYSICIAN'S OFFICE CALLED TO SCHEDULE ADDITIONAL INTERVENTION REGARDING THE WIRE TIP. TWO DAYS POST PROCEDURE THE PATIENT RETURNED. THE PHYSICIAN WAS PLANNING TO ATTEMPT TO COMPRESS AND/OR STENT THE BROKEN TIP OF THE GUIDE WIRE TO THE VESSEL WALL. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. MULTIPLE ATTEMPTS IN CROSSING THE STENTED AREA, USING BOTH BSC AND NON BSC GUIDE WIRES AND BALLOONS, WERE UNSUCCESSFUL. GOOD FLOW THROUGH THE AREA OF PREVIOUS STENTING WAS NOTED. THE NEXT DAY, AFTER SUFFERING A CARDIOPULMONARY ARREST, THE PATIENT HAD RESPIRATORY COMPROMISE, WAS INTUBATED AND TREATED MEDICINALLY AND SUBSEQUENTLY DEVELOPED TACHYARRHYTHMIA. SPONTANEOUS DISCHARGE FOR HIS ICD WAS NOTED AND HE WAS EXTERNALLY DEFIBRILLATED. THE PATIENT ARRESTED A SECOND TIME. AN ART LINE WAS PLACED; CPR AND MEDICINAL INTERVENTION WERE ADMINISTERED. THE PATIENT REMAINED IN EMD THROUGHOUT THE CODE. AFTER GREATER THAN 20 MINUTES OF CONTINUOUS CPR, NO EVIDENCE OF RESPONSE TO MECHANICAL STIMULATION, DRUGS OR PERICARDIOCENTESIS, ATTEMPTS WERE CEASED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203147 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death