BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2993242 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01412
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 13, 2013
    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).

    Additional Manufacturer Narrative · 1

    (B)(6) . DEVICE IS COMBINATION PRODUCT. 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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 BEFORE THE IMPLANTATION OF THE 3.5 X 38 NON BSC STENT IN (B)(6) 2013, TIMI FLOW WAS 0 AND FTER IMPLANTATION TIMI FLOW WAS 3.

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS 2134265-2013-01297, 2134265-2013-01296. SAME CASE AS MDR ID# 2134265-2013-01411. (B)(6) 2012 - THE PATIENT PRESENTED WITH CHEST PAIN AND DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 100% STENOSIS AND WAS 40 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 16 MM TAXUS LIBERTE STENT DISTALLY OVERLAPPING WITH 3.00 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 10%. DURING THE INDEX PROCEDURE, POST DEPLOYMENT OF THE TAXUS LIBERTE STENTS, THE PATIENT EXPERIENCED REPERFUSION DYSRHYTHMIA'S WITH BRADYCARDIA, HYPOTENSION, NAUSEA AND INCREASE IN CHEST PAIN. THE PATIENT WAS TREATED WITH MEDICATIONS WHICH RESOLVED OVER TIME. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND PRASUGREL. (B)(6) 2013 - THE PATIENT PRESENTED WITH CHEST PAIN. CARDIAC ENZYMES WERE NOT DRAWN FOR THIS EVENT. ECG REVEALED PROBABLE INFERIOR INFARCT WITH ST ELEVATION. THE PATIENT WAS DIAGNOSED WITH Q-WAVE ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED IN-STENT RESTENOSIS. THE 100% IN-STENT RESTENOSIS OF PREVIOUSLY PLACED STUDY STENTS WITH THROMBUS IN DISTAL RCA WAS TREATED WITH THROMBECTOMY AND PLACEMENT OF 3.50 X 38 MM NON BSC STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97958 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R