BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3230366 · Received July 16, 2013

    Report

    Report Number
    2134265-2013-04854
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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

    TAXUS LIBERTE CLINICAL TRIAL. SAME CASE AS MDR # 2134265-2013-04857 AND MDR # 2134265-2013-04643. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION (PCI), CORONARY ARTERY DISEASE (CAD) PROGRESSION, IN-STENT RESTENOSIS, ANGINA AND "HAZY LESION" IN PROXIMAL RIGHT CORONARY ARTERY (RCA) OCCURRED. IN (B)(6) 2011, THE PATIENT WAS PRESENTED WITH SEVERE SUBSTERNAL CHEST PRESSURE AND NOTED TO HAVE HAD AN EPISODE OF SYNCOPE. THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AFTER ONE DAY, PCI WAS PERFORMED. THE 12MM IN LENGTH, DE NOVO, 90% STENOSED TARGET LESION # 1 WAS LOCATED IN THE 3.00MM IN DIAMETER PROXIMAL RCA. TARGET LESION #1 WAS TREATED WITH PRE-DILATION FOLLOWED BY PLACEMENT OF A 3.00MM X 12 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. ONE-DAY POST-PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT PRESENTED WITH PROXIMAL EDGE STENOSIS AND FOCAL IN-STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE PROXIMAL RCA. THIS WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50MM X 8 MM PROMUS STENT. PER SOURCE, AN UNKNOWN TAXUS STENT WAS DEPLOYED IN RCA AND AN UNKNOWN TAXUS STENT WAS DEPLOYED IN THE LAD 2008. IN (B)(6) 2012, THE STUDY DRUG WAS LAST TAKEN BY THE PATIENT. IN (B)(6) 2012, THE SUBJECT WAS EXPERIENCING ANGINA. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN WITH PHYSICAL ACTIVITY. STRESS TEST WAS PERFORMED ON THE SAME DAY WHICH SHOWED A NEW APICAL AREA OF ISCHEMIA WITH NORMAL EJECTION FRACTION. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS SUBSEQUENTLY DIAGNOSED WITH PROGRESSION OF CAD. PATIENT WAS HOSPITALIZED ON THE SAME DAY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE SUBJECT WAS ON ASPIRIN AND PRASUGREL. THE 80% DIFFUSE IN-STENT RESTENOSIS OF THE STUDY STENT IN PROXIMAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.00MM X 18MM NON-BSC STENT FOLLOWED BY ANOTHER 3.00MM X 12MM NON-BSC STENT WITH 0% RESIDUAL RESTENOSIS. THE 70% NON-TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.00MM X 18 MM NON-BSC STENT WITH 0% RESIDUAL STENOSIS. PER SOURCE, AN UNKNOWN TAXUS STENT WAS DEPLOYED IN THE NON-TARGET VESSEL MID LAD IN 2008. THE 90% TARGET LESION IN MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.50MM X 18 MM NON-BSC STENT WITH 0% RESIDUAL STENOSIS. AFTER ONE DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND PRASUGREL. TWENTY-ONE DAYS POST DISCHARGE, THE SUBJECT EXPERIENCED ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS ON ASPIRIN AND PRASUGREL. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED AND THE PATIENT WAS TREATED MEDICALLY DURING THE COURSE OF THE EVENT. AFTER 2 DAYS, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    THE UNKNOWN TAXUS STENTS IMPLANTED IN MID LAD AND PROXIMAL RCA IN 2008, PRIOR TO THE STUDY INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329014 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention