BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1771701 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03388
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-03599, 2134265-2010-03672, 2134265-2010-03673, 2134265-2010-03674, 2134265-2010-03675, 2134265-2010-05025. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE THE MID RCA WAS PREDILATED WITH A 3.5X24MM APEX BALLOON AND A 3.5X32MM TAXUS LIBERTE STENT WAS ADVANCED BUT WAS UNABLE TO ACCESS THE DISTAL RCA. THE 3.5X32MM TAXUS LIBERTE WAS DEPLOYED IN THE MID RCA AT 12ATM FOR 20 SECONDS AFTER "EXTENDED EFFORT" TO MAKE THE FINAL TURN INTO THE DISTAL RCA. THEN A 3.5X16MM TAXUS LIBERTE STENT WAS ADVANCED AND ATTEMPTED TO CROSS THE 3.5X32MM IMPLANTED TAXUS LIBERTE STENT, BUT IT COULD NOT CROSS THE PREVIOUS STENT AND WAS DEPLOYED AT THE PROXIMAL RCA AT 18ATM FOR 30 SECONDS WITH 1MM OF OVERLAP ON THE PREVIOUS STENT. THE OVERLAP AREA WAS THEN POST DILATED AT 18ATM FOR 20 SECONDS. THEN ADDITIONAL PREDILATION OF THE DISTAL RCA WAS PERFORMED WITH A 3.5X29MM APEX BALLOON AT 14ATM FOR 30 SECONDS DISTALLY, 18ATM FOR 25 SECONDS AT THE MID PORTION, AND A 3.5X12MM TAXUS LIBERTE STENT WAS ADVANCED TO THE DISTAL RCA AND DEPLOYED WITH 1MM OVERLAP AT 8ATM FOR 30 SECONDS. THE OVERLAP AREA WAS THEN POST DILATED AT 12ATM FOR 20 SECONDS AND THE MID PORTION OF THE VESSEL WAS POST DILATED AT 20ATM FOR 30 SECONDS. SOME RESIDUAL NARROWING WAS NOTED AT THE ORIGINAL IN-STENT RESTENOSIS SITE AND A 4.0X20MM QUANTUM MAVERICK BALLOON COULD NOT CROSS THE LEADING EDGE OF THE MID STENT AND WAS REMOVED. ANOTHER MANUFACTURER'S 4.0X15MM BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH EXCELLENT ANGIOGRAPHIC RESULTS AT THE TREATED SITES. THE PATIENT EXPERIENCED INTERMITTENT ST ELEVATIONS WHICH IMPROVED BUT DID NOT RESOLVE UPON LEAVING THE LAB.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION ONE WAS A 3.7X16MM, 70% STENOSIS OF THE MID RCA. TARGET LESION TWO WAS A 3.2X32MM, 85% STENOSIS OF THE MID RCA. TARGET LESION THREE WAS A 3.5X18MM, 70% STENOSIS OF THE DISTAL RCA. THERE WERE TWO OBSTRUCTIVE LESIONS AT THE AREA OF THE PREVIOUSLY PLACED TAXUS EXPRESS2 STENT IN THE R-PDA (RIGHT POSTERIOR DESCENDING ARTERY) AT THE TIME OF REINTERVENTION. THE R-PDA WAS TREATED WITH PLACEMENT OF A 2.5X24MM NON-BSC STENT. FINAL ANGIOGRAPHY REVEALED EXCELLENT RESULTS. AT THIS TIME, THE LCX (LEFT CIRCUMFLEX) WAS ALSO TREATED WITH PLACEMENT OF A 2.5X24MM NON-BSC STENT. FOLLOWING POST-DILATATIONS, THERE WAS GOOD ANGIOGRAPHIC RESULTS. PER THE SOURCE DOCUMENTS, 'THERE WERE NO INTERVENTIONAL OPTIONS FOR THE RV (RIGHT VENTRICULAR) MARGINAL SIDE BRANCH OCCLUSIONS SINCE THEY ONLY SUPPLIED THE RIGHT VENTRICLE, WERE TOO SMALL FOR REVASCULARIZATION AND WERE INVOLVED WITH STENT JAIL.'

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04408, 2134265-2010-04409. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE IN (B)(6) 2010 THREE TARGET LESIONS WERE TREATED. TARGET LESION ONE IN THE PROXIMAL RCA (RIGHT CORONARY ARTERY) WAS TREATED WITH A 3.5X32MM TAXUS LIBERTE STUDY STENT. TARGET LESION TWO IN THE MID RCA WAS TREATED WITH A 3.5X16MM TAXUS LIBERTE STUDY STENT. TARGET LESION THREE IN THE DISTAL RCA WAS TREATED WITH A 3.5X12MM TAXUS LIBERTE STUDY STENT RESULTING IN A SIDE BRANCH OCCLUSION. THE SAME DAY AS THE INDEX PROCEDURE THE PATIENT WAS TREATED MEDICALLY FOR PNEUMONIA WHICH WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICES. TWENTY ONE DAYS POST PROCEDURE THE PATIENT ALSO EXPERIENCED CHEST PAIN REQUIRING ANGIOGRAPHY WITHOUT REVASCULARIZATION WHICH WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICES.

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, THE PATIENT DEVELOPED A SIDE BRANCH OCCLUSION AND A POST PROCEDURE MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED AN UNSPECIFIED LESION WITH A TAXUS LIBERTE STENT. DURING THE PROCEDURE, A SIDE BRANCH OCCLUSION WAS NOTED. THE SAME DAY, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND WAS TREATED WITH MEDICATION AND A NON-TARGET VESSEL REINTERVENTION. BOTH EVENTS WERE ASSESSED BY THE INVESTIGATOR AS POSSIBLY RELATED TO THE STUDY DEVICE. THE BRANCH OCCLUSION WAS CONSIDERED RESOLVED THE SAME DAY AND THE MI RESOLVED SEVEN DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632350 12562927

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention APEX BALLOONS: 3.5X24MM, 3.5X29MM| 4.0X20MM QUANTUM MAVERICK BALLOON| 4.0X15MM NC SPRINTER BALLOON