BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 3222317 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04720
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG PER PROTOCOL WAS NEVER TAKEN DURING THE COURSE OF THE STUDY.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2013-04719, 2134265-2013-04721, 2134265-2013-04722, 2134265-2013-05030, 2134265-2013-05068. SAME PATIENT AS: 2134265-2011-00017, 2134265-2011-00254, 2134265-2012-05276, 2134265-2012-05277, 2134265-2012-05279. IT WAS REPORTED THAT SUBSEQUENT TO A PERCUTANEOUS CORONARY INTERVENTION, ABNORMAL NUCLEAR PERFUSION SCAN, FATIGUE, SHORTNESS OF BREATH AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2008, TWO PROMUS STENTS WERE DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ON (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION NO. 1 WAS A BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% IN-STENT RESTENOSIS AND WAS 28MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.00MM X 32MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. TARGET LESION NO. 2 WAS A BIFURCATED LESION LOCATED IN THE FIRST DIAGONAL BRANCH WITH 80% IN-STENT STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25MM X 16MM TAXUS LIBERTE STENT AFTER FAILURE TO DEPLOY A PREVIOUS 2.25MM X 16MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. TARGET LESION NO. 3 WAS AN IN-STENT RESTENOTIC LESION, LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY AND WAS 34MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.00MM X 38MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL ONE DAY POST PROCEDURE. ON (B)(6) 2010, PATIENT HAD EXACERBATION OF ANGINA AND WAS TREATED WITH PLACEMENT OF A 3.5MM X 28 MM PROMUS STENT IMPLANTED IN THE PROXIMAL LAD TO MID LAD. ON (B)(6) 2012, THE PATIENT HAD THREE TAXUS ION STENTS (3.00MM X 16MM, 2.75MM X 16MM, AND 2.75MM X 12MM) DEPLOYED IN OBTUSE MARGINAL BRANCH 1 (OM1). IN ADDITION TO THIS A 3.00MM X 38 MM TAXUS ION STENT WAS DEPLOYED IN PROXIMAL LAD TO MID LAD. ON (B)(6) 2013, THE PATIENT PRESENTED DUE TO RECURRENT FATIGUE. STRESS TEST WAS FOUND TO BE ABNORMAL. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED 85% IN-STENT MINIMAL INTIMAL HYPERPLASIA IN THE MID VESSEL OF THE LAD AND 80% TO 90% FOCAL IN-STENT RESTENOSIS OF ION STENTS IN PROXIMAL TO MID CIRCUMFLEX OBTUSE MARGINAL SYSTEM. AN ATTEMPT WAS MADE TO ADVANCE THE FORTE GUIDE WIRE IN THE PROXIMAL TO MID CIRCUMFLEX OBTUSE MARGINAL SYSTEM HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS CHANGED WITH A NON-BSC GUIDEWIRE. THE LESION WAS THEN TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0MM X 16 MM ION STENT IN PROXIMAL TO MID AND 2.5MM X 14MM NON-BSC STENT DISTALLY. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 10%. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324577 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638300 12827095

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention