BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2040407 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-00950
    Event Type
    Death
    Date Received
    April 5, 2011
    Date of Event
    May 27, 2010
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE THE PROXIMAL RCA WAS 75% STENOSED, 3.0MM IN DIAMETER AND 10MM LONG. THE LESION WAS TREATED WITH DEPLOYMENT OF A 3.0X12MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW RESTORED FROM 1 TO 3. THE LESION LOCATED IN THE MID RCA WAS 100% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH PREDILATION AND DEPLOYMENT OF A 2.75X16MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW RESTORED FROM 0 TO 3. THE PATIENT WAS DISCHARGED ON BABYASPIRIN AND PANALDINE WITHOUT ANY COMPLICATION. IN (B)(6) 2011, UNSTABLE ANGINA WAS OBSERVED. THE FOLLOWING DAY, ANGIOGRAPHY REVEALED LESION 2 WAS 3.0MM IN DIAMETER INSTEAD OF 2.75MM IN DIAMETER AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS: 2134265-2011-00951 IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND LATER EXPIRED. IN (B)(6) 2007, THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS EXPRESS2 STENT IN THE PROXIMAL RCA AND ANOTHER UNKNOWN SIZE TAXUS EXPRESS2 STENT IN MID RCA. IN (B)(6) 2010, THE PATIENT INITIALLY HAD CHEST PAIN WHILE DRIVING. HOWEVER, THE SYMPTOMS WAS RESOLVED WITH MEDICATION. CHEST PAIN WAS LATER NOTED, DURING THE TREATMENT OF AN INGROWN TOE NAIL AT ANOTHER FACILITY. ST SEGMENT DEPRESSION (V4-V6) WAS FOUND VIA AN ELECTROCARDIAGRAM (ECG). THE CHEST PAIN RESOLVED BY MEDICATION. THE PATIENT WAS TRANSFERRED TO A STUDY STENT IMPLANT FACILITY. A CORONARY ANGIOGRAM (CAG) WAS PERFORMED. LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DE NOVO TARGET LESION WAS 75% STENOSED, 3.0MM IN DIAMETER AND 10MM LONG. LESION 2 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. THE IN-STENT RESTENOSED LESION WAS 100% STENOSED AND 2.75MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANGINA PECTORIS. LESION 2 WAS DILATED WITH AN UNKNOWN BALLOON. THE PATIENT'S BLOOD PRESSURE DECREASED AFTER DILATION. THE PATIENT DEVELOPED ADAMS-STOKES SYNDROME. NORADRENALIN WOULD NOT SOLVE THE SYMPTOM. THE PATIENT EXPERIENCED CARDIAC ARREST. HOWEVER, HEARTBEAT RECOVERED BY A RESUSCITATION TECHNIQUE. THE PATIENT WAS INTUBATED AND EPINEPHRINE WAS ADMINISTERED. LESION 1 WAS TOTALLY OCCLUDED. THE PHYSICIAN ATTEMPTED DILATING THE LESION WITH AN UNKNOWN BALLOON. THE BALLOON RUPTURED. THE PHYSICIAN SUGGESTED A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, BUT THE PATIENT'S FAMILY DECLINED. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED TO THE PATIENT. THE PATIENT RETURNED TO THE MEDICAL WARD. THE PATIENT EXPIRED LATER THAT DAY. THE CAUSE OF DEATH WAS NOT GIVEN AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897012300 9662970

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death