BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1222849 · Received November 6, 2008

    Report

    Report Number
    2134265-2008-04237
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS TIGHTLY COILED AND THE BALLOON WAS IN A DEFLATED STATE. IT WAS NOTED DURING VISUAL INSPECTION THAT BLOOD WAS PRESENT INSIDE THE BALLOON AND AT SEVERAL LOCATIONS ALONG THE LENGTH OF THE SHAFT. VISUAL AND TACTILE INSPECTION REVEALED NO IRREGULARITIES. THE DEVICE WAS PRESSURIZED WITH AIR USING A 20 CC SYRINGE WHILE SUBMERGING THE SHAFT, BALLOON AND HUB OF THE DEVICE IN AMBIENT WATER. THIS REVEALED A LEAK IN THE DISTAL SHAFT NEAR THE DISTAL END OF THE CORE WIRE. THE DISTAL SHAFT WAS MICROSCOPICALLY EXAMINED TO LOCATE THE SOURCE OF THE LEAK. IT WAS DETERMINED THAT THE SOURCE OF THE LEAK WAS A SLIGHTLY ELONGATED PINHOLE IN THE SHAFT APPROXIMATELY 18.6 CM FROM THE DISTAL TIP. THE PINHOLE AND ADJACENT AREAS OF THE SHAFT WERE MICROSCOPICALLY EXAMINED TO CHARACTERIZE THE HOLE AND DETERMINE IF ANY MATERIAL OR MANUFACTURING DEFICIENCIES MAY HAVE CONTRIBUTED TO THE FORMATION OF THE HOLE. NO MATERIAL OR MANUFACTURING ANOMALIES WERE IDENTIFIED AND IT WAS DETERMINED THAT A SLIGHT BULGE IN THE SHAFT MATERIAL AT THE DISTAL END OF THE HOLE MAY BE INDICATIVE OF INTERACTION WITH A SURFACE OR OBJECT, WHICH LIKELY CREATED THE HOLE. NO SCRATCHES OR OTHER DEFECTS WERE NOTICED ADJACENT TO THE HOLE IN THE DISTAL SHAFT BUT IT IS NOTABLE THAT THE RETURNED CONDITION OF THE DEVICE INCLUDED A SUBSTANTIAL AMOUNT OF DRIED BLOOD AND/OR OTHER BIO-MATERIAL OR CONTRAST MEDIA. THE MANUFACTURING RECORDS WERE REVIEWED TO CONFIRM THAT THERE WERE NO ISSUES OR DISCREPANCIES DURING PRODUCTION OF THE DEVICES IN THIS BATCH THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE IN THIS BATCH MET SPECIFICATION PRIOR TO SHIPMENT. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, AIR EMBOLISM, BRADYCARDIA, LEAK, AND HOLE IN THE SHAFT OCCURRED. THE PT WAS BEING TREATED FOR A 'LOWER INFARCT'. THE 100% LESION BEING TREATED WAS LOCATED IN THE OCCLUDED, MODERATELY TORTUOUS, MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X12MM QUANTUM MAVERICK BALLOON WITH 'INSUFFICIENT RESULTS'. THE SECOND PRE-DILATATION WAS MADE DISTALLY FROM THE LESION WITH A 2X20 APEX. THE PHYSICIAN ATTEMPTED TO DEPLOY THE 2.50X12MM TAXUS LIBERTE STENT, INFLATED 12 ATM FOR 30 SECONDS. HOWEVER, THE STENT WAS INSUFFICIENTLY OPENED 'UPSTREAM'. THE STENT DELIVERY SYSTEM BALLOON WAS THEN USED TO POST-DILATE THE STENT. THE PHYSICIAN NOTICED SOME BUBBLES AT THE LEVEL OF THE LUER-LOCK. THE BUBBLES WERE SENT TO THE CORONARY ARTERY AND CAUSED A 'NO-REFLOW". AFTER A BRADYCARDIA AND AN INJECTION OF RISORDAN, THE PT WAS FINE. WHEN THE STENT DELIVERY BALLOON CATHETER WAS REMOVED IT WAS FOUND TO BE FULL OF BLOOD. THE PHYSICIAN NOTICED A LEAKAGE ON THE HYPOTUBE AND A SMALL HOLE BETWEEN THE BALLOON LUMEN AND THE CATHETER WALL. PT STATUS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.50X12 MM 11462197

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention