BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2834026 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06996
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 11, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. 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 CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: DESCRIBE EVENT OR PROBLEM: PREVIOUSLY REPORTED EVENT OF "TVR IN THE SVG TO OM2" WAS WITHDRAWN. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: DESCRIBE EVENT OR PROBLEM: ISR WAS RELATED TO A NON-BSC STENT INSTEAD OF STUDY STENT OR THE THREE TAXUS LIBERTE STENTS. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MDR ID#S: 2134265-2012-06997, 2134265-2012-06998, 2134265-2012-06999, 2134265-2012-07000, 2134265-2012-07001. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD IN-STENT RESTENOSIS AND REQUIRED A TARGET VESSEL REVASCULARIZATION (TVR). IN (B)(6) 2005, A 3.0X16MM TAXUS LIBERTE STENT WAS PLACED IN THE PROXIMAL RCA. IN (B)(6) 2010, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASS 1) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST TARGET LESION WAS A DE NOVO OSTIAL LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WITH 95% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.5X16MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 2ND TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO 2ND OBTUSE MARGINAL BRANCH (OM2) WITH 95% STENOSIS AND WAS 9MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 4.0X12MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED 75-94% ECCENTRIC RECURRENT RESTENOSIS OF THE 3.5X16MM PROMUS ELEMENT STUDY STENT IN THE PROX RCA, WHICH WAS TREATED WITH PLACEMENT OF A 4X15MM NON-BSC STENT WITH 0% RESIDUAL STENOSIS. THE 95% RESTENOSIS OF THE 4.0X12MM PROMUS ELEMENT STUDY STENT IN THE SVG TO OM2 WAS TREATED WITH PLACEMENT OF A DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. IT WAS ALSO NOTED THERE WAS RESTENOSIS OF THE PREVIOUSLY PLACED 5.0X20MM TAXUS LIBERTE STENT IN THE PROXIMAL SVG TO OM2; RESTENOSIS OF THE PREVIOUSLY PLACED 3.0X16MM TAXUS LIBERTE STENT IN THE DISTAL SVG TO OM2; AND THE PREVIOUSLY PLACED 3.0X16MM TAXUS LIBERTE STENT IN THE PROXIMAL RCA. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE SVG TO 2ND OBTUSE MARGINAL BRANCH (OM2) WAS TREATED WITH PLACEMENT OF A DRUG ELUTING STENT IN (B)(6) 2012, HOWEVER, THE SITE CONFIRMED THERE WAS NO INTERVENTION PERFORMED IN THE SVG TO OM2 AND THIS EVENT WAS ENTERED IN ERROR.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2012, THE 75-94% ECCENTRIC RECURRENT RESTENOSIS IN THE PROXIMAL RCA WAS ONLY RELATED TO A NON-BSC STENT PLACED IN (B)(6) 2011, BUT NOT RELATED TO THE PROMUS ELEMENT STUDY STENT. THE IN-STENT RESTENOSIS WAS TREATED WITH PLACEMENT OF A 4X15MM NON-BSC STENT EXTENDING TO MID RCA WITH 0% RESIDUAL STENOSIS. THE PREVIOUSLY REPORTED IN-STENT RESTENOSIS OF THE THREE TAXUS LIBERTE STENTS HAS BEEN WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016300

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R