BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 4152937 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06002
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 25, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-06537. IT WAS REPORTED THAT STENT THROMBOSIS, MYOCARDIAL INFARCTION AND CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 6FR JR 3.5 NON BSC GUIDE CATHETER WAS PLACED. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, A 2.5X12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PREDILATION. THEN A 3.5X24MM TAXUS¿ LIBERTÉ¿ STENT WAS ADVANCED AND DEPLOYED IN THE DISTAL RCA AT 16 ATMOSPHERES FOR 25 SECONDS. ANOTHER 28MM X 3.50MM TAXUS¿ LIBERTÉ¿ STENT WAS DEPLOYED IN THE PROXIMAL RCA IN AN OVERLAPPING FASHION AT 16 ATMOSPHERES FOR 25 SECONDS. POST DILATION WAS PERFORMED USING A 3.5X12 QUANTUM MAVERICK BALLOON CATHETER AT 18 ATMOSPHERES FOR 25 SECONDS WITH GOOD END RESULT. FOUR DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF SEVERE CHEST PAIN AND WAS DIAGNOSED WITH ACUTE ST ELEVATION INFERIOR WALL MYOCARDIAL INFARCTION (IWMI). IT WAS NOTED THAT THERE WAS AN IN-STENT THROMBOSIS IN THE OSTIO-PROXIMAL RCA. PLAIN OLD BALLOON ANGIOPLASTY WAS DONE MULTIPLE TIMES USING A 4.0X15 NON BSC BALLOON CATHETER AT 14 ATMOSPHERES FOR 30 SECONDS WITH GOOD RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-06537. IT WAS FURTHER REPORTED THAT THE 3.5X24MM TAXUS LIBERTE STENT WHICH WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY WAS PATENT AND FREE OF THROMBOSIS. HOSPITALIZATION WAS PROLONGED AFTER THE PATIENT WAS DIAGNOSED WITH ACUTE ST ELEVATION INFERIOR WALL MYOCARDIAL INFARCTION (IWMI) FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632228 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894028350

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R GUIDE CATHETER: LAUNCHER 6FR JR 3.5| GUIDE WIRE: PILOT 50| BALLOON CATHETER: 2.5X12 MAVERICK