BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 884365 · Received July 23, 2007

    Report

    Report Number
    6000089-2007-01012
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    April 10, 2007
    Report Date
    July 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. DEVICE ANALYSIS CAN CONFIRM THE COMPLAINT THE COMPLAINANT REPORTED. THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK THAT OCCURRED IN THE HYPOTUBE. THE BREAK WAS MEASURED AT APPROXIMATELY 17.4 CM DISTAL FROM THE STRAIN RELIEF. THE DEVICE APPEARED TO HAVE BEEN KINKED AT THE POINT OF SEPARATION. MICROSCOPIC EXAMINATION OF THE CRIMPED STENT AND TIP FOUND NO ISSUES. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. A RECOMMENDED SIZE GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. IN THE COMPLAINT REPORT IT IS NOTED THAT THE LESION WAS SEVERELY CALCIFIED. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE DIFFICULTIES EXPERIENCED BY THE PHYSICIAN DURING THE USE OF THIS DEVICE. LESIONS THAT ARE SEVERELY CALCIFIED ARE CONTRAINDICATED IN THE TAXUS EXPRESS 2 DIRECTIONS FOR USE. A REVIEW OF TOP ASSEMBLY SHOP FLOOR PAPERWORK BATCH # 8812112 AND THE SUB ASSEMBLY SHOP FLOOR PAPERWORK BATCH # 8797226 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE COMPLAINT INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS APPROVED IN 07/18/2007. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE SHAFT BROKE AT THE HUB. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THE SHAFT BROKE 17.4 CM DISTAL FROM THE STRAIN RELIEF. THE PHYSICIAN WAS ATTEMPTING TO TREAT THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN HAD SUCCESSFULLY DEPLOYED TWO 2.75 X 32 MM TAXUS EXPRESS2 DRUG ELUTING STENTS IN THE LAD. THE PHYSICIAN INSERTED AND ADVANCED A .014 HI TORQ EXTRA S'PORT ST GUIDEWIRE AND A 2.5 X 15 MM MAVERICK II RX BALLOON. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATMS) FOR 17 SECONDS (SECS), 10 ATMS FOR 18 SECS AND 12 ATMS FOR 17 SECONDS. THE 2.5 X 2 MM TAXUS EXPRESS2 DES WAS INSERTED AND WHILE ADVANCING THE STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, THE SHAFT BROKE BY THE HUB OUTSIDE THE PATIENT'S BODY. THE STENT AND SDS WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED BY IMPLANTED A 2.5 X 23 MM NON-BSC BARE METAL STENT. THE PATIENT WAS GIVEN NITROGLYCERIN, HEPARIN, BENADRYL, VERSED, INTEGRILIN, CARDIZEM, VISIPAQUE, NEO-SYNEPHRINE, MORPHINE AND DIGOXIN DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CONDITION LISTED AS "COOPERATIVE, ORIENTED, TRANQUIL, RAMSEY SCORE 2" AT THE END OF THE PROCEDURE AND WAS TRANSFERRED TO CCU.

    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 2.5 X 20 MM 8812112

    Patients

    Seq Age Sex Outcome Treatment
    1 YR FLEXOR RAABE SHEATH