BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003536 · Received February 26, 2008

    Report

    Report Number
    2134265-2008-00560
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    November 28, 2007
    Report Date
    February 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT AN ANALYSIS OF THE COMPLAINT DEVICE IT WAS NOT POSSIBLE TO DETERMINE IF ANY DEVICE ANOMALIES EXISTED THAT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS DUE TO 'ANTICIPATED PROCEDURAL COMPLICATIONS' DUE TO THE LIKELIHOOD THAT THE PATIENT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY, AND DUE TO THE ABSENCE OF INFORMATION IMPLICATING A ROOT CAUSE RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED 02/01/2008. IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THAT MUSCLE WEAKNESS, NO STAMINA, FATIGUE AND INTERMITTENT SHORTNESS OF BREATH WERE EXPERIENCED. THE PATIENT ALSO REPORTED THAT ONE OF HER PROCEDURE WAS INTERRUPTED DUE TO "SIGNIFICANT" BLEEDING FROM THE FEMORAL ARTERY AND THAT SHE BLEEDS FROM HER FINGER FOR "TWO HOURS AFTER A SIMPLE CUT". HOWEVER, PER PROCEDURE NOTES RECEIVED, A DISSECTION OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO AN ACUTE ST-ELEVATION INFERIOR MYOCARDIAL INFARCTION AND CHEST PAIN. DIRECT STENTING OF THE POSTERIOR DESCENDING ARTERY (PDA) WAS PERFORMED WITH A 2.25X13MM NON-BSC BARE METAL STENT. A 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). BOTH STENTS HAD "EXCELLENT ANGIOGRAPHIC RESULTS". THE PATIENT'S ELECTROCARDIOGRAM RETURNED TO "NORMAL" AND THE PATIENT'S CHEST PAIN RESOLVED. DUE TO AN EXPANDING FEMORAL HEMATOMA IN THE RIGHT GROIN, THE PROCEDURE WAS DISCONTINUED. TWO DAYS LATER, THE PATIENT HAD BEEN PRETREATED WITH ASPIRIN AND PLAVIX. A 2.25X13MM NON-BSC BMS WAS IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25X18MM NON-BSC BMS WAS IMPLANTED IN THE MID LAD. A 2.5X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL LAD. A FLAP DISSECTION INVOLVING THE PROXIMAL MARGIN OF THE STENT WAS NOTICED. A 3.0X8MM TAXUS EXPRESS2 DES WAS SUCCESSFULLY IMPLANTED TO TREAT THE DISSECTION. A 2.25X18MM NON-BSC WAS IMPLANTED IN THE 2ND OBTUSE MARGINAL (OM) ARTERY. A 2.25X8MM QUANTUM BALLOON WAS USED TO POSTDILATE THE NON-BSC BMS WITH EXCELLENT ANGIOGRAPHIC RESULTS AND NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH THE FOLLOWING MEDICATIONS: ASPIRIN 81MG DAILY, PLAVIX 75MG DAILY, LISINOPRIL 10MG DAILY, SIMVASTATIN 40MG DAILY, HYDROCODONE 10/325 PRN Q4H AS NEEDED, SYNTHROID 50 MCG DAILY, BETAXOL 1 DROP TO BOTH EYES BID, SOMA 350MG AS NEEDED FOR MUSCLE SPASMS. THE PATIENT'S RIGHT GROIN HEMATOMA WAS REPORTED AS "TENDER" AND MODERATELY SIZED. DORSALIS PEDIS PULSES WERE 2+ BILATERALLY WITH NO PERIPHERAL EDEMA. THIRTY SIX DAYS LATER, THE PATIENT RETURNED FOR A FOLLOW UP CLINIC VISIT. THE PATIENT'S SYNTHROID HAD BEEN "RECENTLY" CHANGED TO 100MCG DAILY. THE PATIENT'S SIMVASTATIN WAS EXCHANGED FOR ZETIA 10MG DAILY. THE PATIENT'S MEDICATION LIST NOW ALSO INCLUDES COENZYME Q10 DAILY, INSULIN REGULAR SLIDING SCALE 5-25 UNITS, LANTUS 50 UNITS Q HS. NO FURTHER LEG WEAKNESS OR PAIN, NO CHEST PAIN. GROIN IS LESS TENDER. BILATERAL FEMORAL AND POSTERIOR TIBIAL PULSES WERE 2+.

    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 2.5X20MM 9736709

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R 2.25X13MM| 2.25X18MM PIXEL BMS| 2.25X13MM MULTI-LENGTH PIXEL BMS