BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 2.5 X 16MM

    MDR report key: 770680 · Received October 17, 2006

    Report

    Report Number
    MW1040714
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    September 14, 2006
    Report Date
    October 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO MEDICAL CENTER. STATED ARRIVAL WAS THERE ABOUT 30 MINUTES AFTER ONSET OF SYMPTOMS. HE HAD A TACHY CARDIAC ARREST REQUIRING MULTIPLE DEFIBRILLATIONS AND INTUBATION. HIS MEDICAL TREATMENT INCLUDED RETAVASE. HE WAS SUBSEQUENTLY TAKEN TO THE CATH LAB TWO DAYS LATER, WHERE A 99% PROXIMAL LAD STENOSIS WAS FOUND. HE WAS TRANSFERRED TO RPTR'S HOSPITAL FOR A PCI. HIS FIRST DOSE OF PLAVIX WAS PRIOR TO THE TRANSFER. PATIENT TAKEN TO THE CATH LAB FOR PCI THE NEXT DAY AT 1534. HEPARIN 4,000 UNITS WERE GIVEN. A TAXUS EXPRESS2 OTW 2.5 X 16MM -LOT #8469368- WAS DEPLOYED TO 12 ATMOSPHERES FOR 20 SECONDS INTO THE PROXIMAL LAD. NO POST DILATIONS WERE DONE. PATIENT COMPLAINED OF CONTINUING AND INTENSIFYING PAIN AND WAS TAKEN BACK TO THE CATH LAB AT 1756. THE CATH DEMONSTRATED CONTINUED PATENCY OF THE STENTED AREA. IT WAS NOTED THERE WAS A 50% OSTIAL STENOSIS OF THE LAD WHICH HAD BEEN PRESENT IN EARYLY CATHS. PATIENT TAKEN BACK TO THE CATH LAB 2 DAYS LATER AT 1207 WITH CONTINUING CHEST PAIN. ANGIOMAX BOLUS OF 10.5CC WAS GIVEN AND DRIP STARTED AT 25CC PER HOUR. A TAXUS EXPRESS2 OTW 3.0 X 20MM -LOT #8447420- WAS DEPLOYED INTO THE OSTIAL/PROXIMAL LAD INFLATING TWICE TO 12 ATMOSPHERES FOR 20 SECOND. PATIENT TAKEN BACK TO THE CATH LAB AGAIN THE NEXT DAY AT 0334 AFTER DEVELOPING ACS WITH ST ELEVATION. INTEGRILIN BOLUS AT 6.2CC WAS GIVEN AND DRIP STARTED AT 11CC PER HOUR. THE CATH DEMONSTRATED TOTAL OCCLUSION IN THE MORE DISTAL STENT OF THE LAD. HEPARIN BOLUS OF 7,500 UNITS WAS GIVEN. A MAVERICK BALLOON OTW 3.0 X 20MM -LOT #8755651- WAS FIRST USED TO DILATE. THEN A QUANTUM MAVERICK BALLOON3.0 X 15MM -LOT #8864727- WAS USED FROM 2 OR 3 INFLATIONS UP TO 20 ATMOSPHERES FOR 20 SECONDS. A TAXUS EXPRESS2 OTW 3.0 X 16MM -LOT #8704390- WAS DEPLOYED UP TO 16 ATMOSPHERES FOR 20 SECONDS WITHIN PREVIOUS STENT. A TAXUS EXPRESS2 RX 2.5 X 24MM -LOT #8380847- WAS PLACED DISTAL TO PREVIOUS STENT AND DEPLOYED TWICE UP TO 12 ATMOSPHERES FOR 20 SECOND. SUPPLEMENTAL CARDENE 200 MCG WAS ADMINISTERED INTRACORONARY TWICE. CONTINUED TO RECEIVE PLAVIX AND WAS DISCHARGED HOME ON PLAVIX 75MG DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 2.5 X 16MM * NIQ BOSTON SCIENTIFIC CORPORATION TAXUS EXPRESS2 OTW 8465368

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| S