BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2022085 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00980
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(4). 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).

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT HISTORY UPDATED.(B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS PRE-DILATED WITH A 2.5 MM BALLOON. FOLLOWING THIS DILATION THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. THE PATIENT WAS CARDIOVERTED TWICE RESULTING IN SINUS BRADYCARDIA. AT THE TIME OF THE ADVERSE EVENT, THE PATIENT WAS ADMITTED WITH SUBSTERNAL CHEST PAIN RADIATING TO HIS BACK. EKG REVEALED ANTERIOR ST ELEVATION MYOCARDIAL INFARCTION. INITIAL TROPONIN AND MB WERE NEGATIVE AND SECOND SET WAS POSITIVE FOR MYOCARDIAL DAMAGE. CHEST X-RAY REVEALED NO ACUTE CHANGES SINCE PREVIOUS EXAM. THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD IN-STENT RESTENOSIS WITH 100% OCCLUSION AND TIMI 0 FLOW. THE MID LAD STENT WAS RE-DILATED WITH A 3.0 MM BALLOON RESULTING IN A NON-FLOW LIMITING DISSECTION DISTAL TO THE STENT. THE DISSECTION WAS COVERED WITH A 2.5 X 16 MM TAXUS LIBERTE STENT WHICH WAS POST-DILATED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED WITH ANTIPLATELET THERAPY BEING REINSTITUTED..

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND STENT THROMBOSIS. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 100% STENOSES AND A POSSIBLE THROMBUS PRESENT. THE LESION WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING OF A 2.75 MM X 28 MM (B)(4) STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS POST PROCEDURE ON ASPIRIN AND PRASUGREL. (B)(4) POST INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CHEST PAIN AND WAS DIAGNOSED WITH A ST ELEVATION MYOCARDIAL INFARCTION. IT WAS NOTED THAT THE PATIENT WAS NONCOMPLIANT WITH THE MEDICATIONS FOR THE LAST SEVERAL DAYS. THE PATIENT WAS TREATED WITH MEDICAL THERAPY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED THE LAD WAS TOTALLY OCCLUDED AT THE SITE OF THE STENT. A STENT THROMBOSIS WITH 100% STENOSIS WAS REPORTED. THE PHYSICIAN TREATED THE MID LAD WITH BALLOON ANGIOPLASTY, AND IMPLANTING A 2.5 X 16 MM (B)(4) STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND STENT THROMBOSIS. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 100% STENOSES AND A POSSIBLE THROMBUS PRESENT. THE LESION WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING OF A 2.75 MM X 28 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS POST PROCEDURE ON ASPIRIN AND PRASUGREL. 116 POST INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CHEST PAIN AND WAS DIAGNOSED WITH A ST ELEVATION MYOCARDIAL INFARCTION. IT WAS NOTED THAT THE PATIENT WAS NONCOMPLIANT WITH THE MEDICATIONS FOR THE LAST SEVERAL DAYS. THE PATIENT WAS TREATED WITH MEDICAL THERAPY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED THE LAD WAS TOTALLY OCCLUDED AT THE SITE OF THE STENT. A STENT THROMBOSIS WITH 100% STENOSIS WAS REPORTED. THE PHYSICIAN TREATED THE MID LAD WITH BALLOON ANGIOPLASTY, AND IMPLANTING A 2.5 X 16 MM TAXUS LIBERTE STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628270 13671403

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention