BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1023698 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00945
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A BALLOON PINHOLE RUPTURE AND DEPLOYMENT DIFFICULTY OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.0X24CM DRUG ELUTING STENT TO THE 90% STENOSED LESION LOCATED IN THE CALCIFIED, EXTREMELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO CROSS THE LESION. AN IVUS CATHETER WAS ALSO UNABLE TO CROSS THE LESION. THE LESION WAS THEN PRE-DILATED SEVERAL TIMES WITH A NON BSC 2.5X15MM BALLOON. THE TAXUS 3.0X24MM STENT WAS ABLE TO CROSS THE LESION. AN ATTEMPT WAS MADE TO DILATE THE STENT BALLOON, BUT IT WOULD ONLY DILATE UP TO 5 ATMS. THE DISTAL SIDE OF THE BALLOON WAS "PINHOLE RUPTURED." UPON WITHDRAWAL, THE STENT DELIVERY SYSTEM CAUGHT ON "SOMETHING" IN THE MID RCA. THERE WAS A LESION LOCATED IN THE MID RCA, SO THE 3.0X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED THERE AT A LOW PRESSURE. IVUS WAS THEN PERFORMED AND IT WAS NOTED THAT PART OF THE STENT WAS DILATED INCOMPLETELY. POST DILATATION WAS THEN PERFORMED WITH THE NON BSC BALLOON. IVUS CONFIRMED COMPLETE STENT WAS THEN IMPLANTED DISTAL TO THE 3.0X24MM STENT AND A TAXUS 3.5X28MM DRUG ELUTING STENT WAS IMPLANTED PROXIMAL TO THE 3.0X24MM STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC H7493897024300

    Patients

    Seq Age Sex Outcome Treatment
    1 RYUJIN BALLOON