BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1881706 · Received October 25, 2010

    Report

    Report Number
    2134265-2010-04766
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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).

    Description of Event or Problem · 1

    (B)(4) CLINCIAL STUDY.IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS.DUE TO SYMPTOMATIC ANGINA, THE PATIENT UNDERWENT AN ANGIOGRAM REVEALING A 99% STENOSED TARGET LESION EXTENDING FROM THE PROTECTED LEFT MAIN ARTERY INTO THE RAMUS ARTERY. THE INDEX PROCEDURE TREATMENT CONSISTED OF PRE-DILATION WITH A 1.5MM BALLOON, FOLLOWED BY A 2.5MM BALLOON AND PLACED A 2.5X12MM TAXUS LIBERTE STUDY STENT. POST PROCEDURE ANGIOGRAPHY REVEALED NO SIGNIFICANT RESIDUAL STENOSIS, NO EVIDENCE OF DISSECTION AND NO EVIDENCE OF PERFORATION. THE STENT PLACED RESULTED IN THE CIRCUMFLEX ARTERY BEING JAILED OFF. A 70% STENOSIS IN THE DISTAL CIRCUMFLEX WAS TO BE TREATED MEDICALLY INITIALLY, HOWEVER, IT WAS REPORTED THAT THE FLOW DOWN THE CIRCUMFLEX WAS MARKEDLY IMPROVED AFTER THE INTERVENTION. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH CARDIAC CHEST PAIN AND WAS RE-ADMITTED TO THE HOSPITAL. ANGIOGRAPHY TWO DAYS LATER REVEALED THE PROXIMAL PORTION OF THE CIRCUMFLEX GAVE RISE TO A RAMUS BRANCH WHICH HAD A 99% RESTENOSIS AS IT COMES OUT OF THE LEFT MAIN. THE PROXIMAL CIRCUMFLEX ITSELF WAS REPORTED TO LOOK ANGIOGRAPHICALLY WELL, BUT ON IVUS THERE WAS DIFFUSE DISEASE THROUGHOUT UP TO 80%. A 3.0X12MM NON SPECIFIED DRUG ELUTING STENT WAS DEPLOYED TO THE MID CIRCUMFLEX AND REDUCED THE LESION TO 0%. BALLOON ANGIOPLASTY WAS ALSO PERFORMED TO THE PROXIMAL CIRCUMFLEX. THE TIGHT RESTENOSIS WITHIN THE STENT EXTENDING FROM THE LEFT MAIN INTO THE RAMUS ARTERY WAS IMPROVED FROM 80% DOWN TO 20-30% WITH MULTIPLE HIGH PRESSURE INFLATIONS. THERE WAS SOME DISSECTION NOTED DISTALLY IN THE CIRCUMFLEX THAT WAS CONSIDERED NOT FLOW LIMITING AND THE PHYSICIAN DECIDED TO NOT TREAT THIS DISSECTION. THE PHYSICIAN NOTED MULTIPLE DIFFUSE LESIONS AND THAT THE VESSELS WERE TOO SMALL AND DIFFUSE TO BE CONSIDERED FOR BYPASS SURGERY. HOWEVER, IT WAS REPORTED THAT THERE DID NOT APPEAR TO BE ANY LARGE AREA OF MYOCARDIUM AT RISK AND HIS LV FUNCTION REMAINS PRESERVED. MEDICAL MANAGEMENT WAS DECIDED BY THE SITE TO BE THE BEST LONG TERM OPTION. TWO DAYS LATER, THE PATIENT EXPERIENCED AN EPISODE OF ATRIAL FIBRILLATION AND THE PATIENT WAS TREATED WITH CARDIOZEM. TWO DAYS LATER, THE PATIENT WAS SCHEDULED TO BE DISCHARGED BUT COMPLAINED OF A PRODUCTIVE COUGH. THE PATIENT WAS DIURESED AND ALSO EXPERIENCED A BOWEL MOVEMENT. THE NEXT DAY, THE PATIENT WAS CONSIDERED TO HAVE REACHED MAXIMAL HOSPITAL BENEFITS AND WAS DISCHARGED FROM THE HOSPITAL. PER THE PHYSICIAN, THE CHEST PAIN EVENT, RESTENOSIS OF INDEX STENT AND ATRIAL FIBRILLATION EVENT WERE LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    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 - MAPLE GROVE H7493893612250 12863182

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R