BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1912045 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05259
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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)(6).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN AND A MYOCARDIAL INFARCTION. AN UNSPECIFIED TAXUS LIBERTE STENT WAS IMPLANTED IN A UNSPECIFIED VESSEL. AFTER THE INDEX PROCEDURE, PRIOR TO DISCHARGE THE PATIENT EXPERIENCED RECURRENT CHEST PAIN LASTING GREATER THAN 20 MINUTES. AN ECG AND ANGIOGRAPHY WITHOUT REVASCULARIZATION WERE PERFORMED AND CARDIAC ENZYMES WERE DRAWN REVEALING THAT THE PATIENT HAD A NON Q WAVE MYOCARDIAL INFARCTION POST PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH THE EVENT LISTED AS RESOLVED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-00272. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE RAMUS WITH 70% STENOSIS AND WAS 35 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH A 3.50 MM X 28 MM TAXUS LIBERTE STENT WHICH APPEARED OVERSIZED COMPARED TO THE REST OF THE ARTERY. IVUS RULED OUT DISTAL EDGE DISSECTION HOWEVER THERE WAS A 50% STENOSIS WHICH WAS TREATED WITH A 2.75 X 12MM TAXUS LIBERTE STENT THAT OVERLAPPED THE PREVIOUS STENT DISTALLY. THERE WAS 0% RESIDUAL STENOSIS. THE NEXT DAY, AN EKG REVEALED MILD LATERAL ST CHANGES WITH T INVERSION AND ELEVATED CARDIAC ENZYMES. THE PATIENT UNDERWENT REPEAT CARDIAC CATHETERIZATION WHICH REVEALED NO SIGNIFICANT CHANGES IN CORONARY ANATOMY SINCE PCI. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628350 13206621

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 2.75X12MM TAXUS LIBERTE STENT