BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072710 · Received April 29, 2011

    Report

    Report Number
    2134265-2011-01548
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). 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. 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

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE EVENT, THE AREA WAS INITIALLY TREATED WITH A 2.75X8MM QUANTUM APEX NON-COMPLIANT BALLOON INFLATED TO 20ATM FOR 10 SECONDS AND A 3.0X8MM QUANTUM APEX NON-COMPLIANT BALLOON INFLATED TO 12ATM FOR 5 SECONDS AND AGAIN TO 20ATM FOR 10 SECONDS. A 3.0X8MM TAXUS LIBERTE STENT WAS DEPLOYED AT 9ATM FOR 20 SECONDS. THE RESULTING PLAQUE SHIFT WAS THEN TREATED WITH A 2.0X8MM APEX BALLOON INFLATED TO 6ATM FOR 10 SECONDS.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MFR ID#: 2134265-2011-01768. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED AND POST PROCEDURE, THROMBOSIS OCCURRED. THE PATIENT WAS ADMITTED DUE TO A Q-WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION (KILLIP CLASSIFICATION I). ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. CARDIAC CATHETERIZATION REVEALED A 99% STENOSED AND 10MM LONG, TYPE B1 TARGET LESION WITH POSSIBLE THROMBUS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. AT THE TIME OF THE PROCEDURE, THE PATIENT WAS GIVEN ASPIRIN 324MG AND CLOPIDOGREL 300MG. USING A 6F, JL4 GUIDE CATHETER AND A 0.014 KINETIX GUIDE WIRE, THE LESION WAS ACCESSED. A 2.5X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED FOR DIRECT STENTING. INITIALLY IT COULD NOT PASS THE OSTIUM OF THE LAD. A "GUIDE LINER" WAS ADVANCED WHICH ALLOWED FOR PASSAGE OF THE STENT DELIVERY SYSTEM. IT WAS DEPLOYED AT 10ATM AND POST DILATION WAS COMPLETED WITH A 2.5MM NON-COMPLIANT BALLOON INFLATED TO 20ATM RESULTING IN 0% RESIDUAL STENOSIS, TIMI-3 FLOW AND NO THROMBUS NOTED. THERE WERE NO IMMEDIATE COMPLICATIONS. THE NEXT DAY, THE PATIENT DEVELOPED "CRUSHING SUBSTERNAL CHEST PRESSURE REMINISCENT OF THE PREVIOUS ANGINA. AT THE TIME OF THE EVENT, THE PATIENT'S ANTIPLATELET THERAPY INCLUDED ASPIRIN 325MG QD, PRASUGREL 75MG QD. THE PAIN PERSISTED FOLLOWING ANALGESIA. ECG REVEALED NO ACUTE CHANGES, HOWEVER FOLLOW UP CARDIAC CATHETERIZATION WAS RECOMMENDED. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY AND USING A 6F DIAGNOSTIC CATHETER, ANGIOGRAPHY WAS PERFORMED AND REVEALED A HAZY NARROWING AT THE PROXIMAL SEGMENT OF THE LAD AT THE SITE OF THE PREVIOUSLY PLACED TAXUS LIBERTE STENT. "SOME THROMBUS MAY BE PRESENT BUT IT ALSO APPEARED THAT PART OF THE VERY PROXIMAL PORTION OF THE LAD MAY HAVE DISSECTED SLIGHTLY". PER THE PHYSICIAN "I SUSPECT THERE WAS A PROXIMAL DISSECTION FROM THE STENT DEPLOYED YESTERDAY". THE AREA WAS DILATED WITH A 2.75MM AND THEN A 3.0MM NON-COMPLIANT BALLOON. RESIDUAL HAZINESS PERSISTED. A 3.0X8MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING RIGHT AFTER THE BIFURCATION OF THE DIAGONAL BRANCH SLIGHTLY PROXIMAL TO THE PREVIOUSLY DEPLOYED TAXUS LIBERTE STENT. THE HAZINESS WAS REDUCED, BUT THERE WAS SOME PLAQUE SHIFTING INTO THE DIAGONAL. THIS WAS TREATED WITH DILATION USING A 2.0MM BALLOON RESULTING IN SATISFACTORY ANGIOGRAPHIC RESULTS WITH 0% RESIDUAL STENOSIS. DURING THE REINTERVENTION, THE PHYSICIAN NOTED A GUIDE WIRE SPASM WHILE OPERATING A NON-BSC GUIDE WIRE. IT MADE THE CONDITION OF THE DISTAL LAD APPEAR MORE SIGNIFICANT BUT IT RESOLVED WITH INTRACORONARY NITROPRUSSIDE. THE DISTAL LAD WILL BE TREATED WITH CONTINUED MEDICAL THERAPY. AT THE TIME OF THE EVENT, THE PATIENT'S ANTIPLATELET THERAPY INCLUDED ASPIRIN 325MG QD, PRASUGREL 75MG QD. THE PATIENT WAS REPORTED TO HAVE ELEVATED CARDIAC ENZYMES (PEAK TROPONIN OF 0.4 UNITS NOT PROVIDED AN A BNP OF 8926 UNITS NOT PROVIDED) DURING HER HOSPITAL STAY. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. HOWEVER THE PATIENT CONTINUED TO EXPERIENCE SOME "PLEURITIC-TYPE CHEST PAIN TO THE LEFT SIDE", BUT AT DISCHARGE WAS REPORTED TO BE GETTING BETTER. THE PATIENT WAS DISCHARGED IN STABLE CONDITION 3 DAYS LATER ON ASPIRIN AND PRASUGREL. THE EVENT CONTRIBUTED TO AN EXTENDED HOSPITALIZATION. IT IS THE OPINION OF THE PHYSICIAN THAT THERE IS A RELATIONSHIP BETWEEN THE EVENT AND THE TAXUS LIBERTE (B)(4) 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 H7493893616250 13970202

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 0.014" KINETIX GUIDE WIRE