BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941239 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05862
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND SLOW FLOW. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY WITH 95% STENOSIS, 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.7 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION USING A 3.0 X 10 MM NON BSC BALLOON. WHEN THE BALLOON WAS REMOVED, THE PATIENT EXPERIENCED SIGNIFICANT CHEST DISCOMFORT AND HAD NOTICEABLE SLOWING OF THE FLOW DOWN THE MID AND DISTAL LAD CONSISTENT WITH MICROEMBOLIZATION. THE PATIENT WAS TREATED WITH 1 MG OF VERAPAMIL. HE ALSO DEVELOPED APPARENT VASOVAGAL REACTION AND BRADYCARDIA WITH HEART RATE DOWN TO APPROXIMATELY 40 AND SOME TRANSIENT HYPOTENSION WITH BLOOD PRESSURE DOWN TO 70 MMHG. HE WAS TREATED WITH ATROPINE 1 MG INTRAVENOUSLY AND INCREASING HIS IV FLUIDS TO 500 CC FOR ABOUT AN HOUR. ONCE HEART RATE INCREASED AND BLOOD PRESSURE NORMALIZED, A 3.5 X 20 MM TAXUS LIBERTE STENT WAS IMPLANTED AT 20 ATM. POST-DILATATION WAS PERFORMED WITH A 4.0 X 10 MM NON BSC BALLOON WITH TWO OVERLAPPING INFLATIONS AT 18 ATM. THE BALLOON WAS REMOVED AND RESIDUAL STENOSIS WAS 0%. HOWEVER, THE PATIENT DEVELOPED MORE SEVERE SLOWING OF FLOW DOWN THE MID AND DISTAL LAD AGAIN, CONSISTENT WITH DISTAL MICROEMBOLIZATION. THE PATIENT WAS TREATED WITH 60 MCG ADENOSINE WITH RETURN OF FLOW TO TIMI-3 WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS ALSO GIVEN 10 MG OF MORPHINE SULFATE FOR CHEST DISCOMFORT DURING THIS PROCEDURE. THE PATIENT STILL HAD SOME MILD RESIDUAL CHEST TIGHTNESS HOWEVER THIS WAS CONSIDERED SIGNIFICANTLY IMPROVED. 1 DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MI. NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED LATER THAT DAY ON ASPIRIN AND PRASUGREL.

    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 H7493893620350 13430067

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 3.0 X 10 MM CORDIS FIRESTAR BALLOON| 4.0 X 10 MM CORDIS DURASTAR BALLOON