BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1658181 · Received April 13, 2010

    Report

    Report Number
    2134265-2010-01774
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    October 22, 2009
    Report Date
    March 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    (B) (4). SAME CASE AS MFR REPORT #: 2134265-2010-01775. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE DE NOVO, 90% STENOSED 3.5X60MM TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED TWO OVERLAPPING 3.5X32MM TAXUS EXPRESS2 STUDY STENTS. POST DILATION WAS PERFORMED WITH AN UNSPECIFIED 4.0X20MM BALLOON. IVUS WAS PERFORMED CONFIRMING THE STENTS WERE WELL APPOSED RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON BAYASPIRIN AND PLETAAL. NO ANGINAL SYMPTOMS WERE PRESENT AT THE 1, 6, 9 & 12 MONTH FOLLOW UP VISITS. IN (B) (6) 2009, THE PATIENT WAS HOSPITALIZED WITH CONGESTIVE HEART FAILURE (CHF). LASIX WAS ADMINISTERED WITH IMPROVED OUTCOME IN (B) (6) 2009. IN (B) (6) 2010, THE PATIENT AGAIN DEVELOPED CHF AND ALSO PNEUMONITIS AND WAS HOSPITALIZED. THE PHYSICIAN NOTED THAT THE PATIENT HAD DEVELOPED CHF SEVERAL TIMES BEFORE THE INDEX PROCEDURE AND WAS UNDER TREATMENT FOR CHRONIC RENAL FAILURE AND CARDIAC VALVULAR DISEASE. ADDITIONALLY, THE PATIENT SUPERVENED PNEUMONITIS RELATED TO DECREASED STRENGTH. TREATMENT DURING HOSPITALIZATION INCLUDED LASIX, ALBUMIN, ALDACTONE AND OXYGEN. THE PATIENT DIED 8 DAYS LATER. NO AUTOPSY WAS PERFORMED. PER THE PHYSICIAN, THE STUDY STENTS WERE "UNRELATED" TO THE ADVERSE EVENTS.

    Description of Event or Problem · 1

    (B) (4). SAME CASE AS MFR REPORT #: 2134265-2010-01775. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE DE NOVO, 90% STENOSED 3.5X60MM TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED TWO OVERLAPPING 3.5X32MM TAXUS EXPRESS2 STUDY STENTS. POST DILATION WAS PERFORMED WITH AN UNSPECIFIED 4.0X20MM BALLOON. IVUS WAS PERFORMED CONFIRMING THE STENTS WERE WELL APPOSED RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON BAYASPIRIN AND PLETAAL. NO ANGINAL SYMPTOMS WERE PRESENT AT THE 1, 6, 9 & 12 MONTH FOLLOW UP VISITS. IN (B) (6) 2009, THE PATIENT WAS HOSPITALIZED WITH CONGESTIVE HEART FAILURE (CHF). LASIX WAS ADMINISTERED WITH IMPROVED OUTCOME IN (B) (6) 2009. IN (B) (6) 2010, THE PATIENT AGAIN DEVELOPED CHF AND ALSO PNEUMONITIS AND WAS HOSPITALIZED. THE PHYSICIAN NOTED THAT THE PATIENT HAD DEVELOPED CHF SEVERAL TIMES BEFORE THE INDEX PROCEDURE AND WAS UNDER TREATMENT FOR CHRONIC RENAL FAILURE AND CARDIAC VALVULAR DISEASE. ADDITIONALLY, THE PATIENT SUPERVENED PNEUMONITIS RELATED TO DECREASED STRENGTH. TREATMENT DURING HOSPITALIZATION INCLUDED LASIX, ALBUMIN, ALDACTONE AND OXYGEN. THE PATIENT DIED 8 DAYS LATER. NO AUTOPSY WAS PERFORMED. PER THE PHYSICIAN, THE STUDY STENTS WERE "UNRELATED" TO THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897032350 11320983

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H