BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2770983 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05953
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS AND CHEST PAIN. IN (B)(6) 2012, THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DIRECT STENTED WITH A 3.0X16MM PROMUS ELEMENT DEPLOYED AT 14 ATM FOR 10 SECONDS. FINAL RESULT WAS "GOOD" WITH TIMI FLOW 3. IN (B)(6) 2012, THE PATIENT RETURNED WITH SEVERE CHEST PAIN. ANGIOGRAPHY REVEALED 100% IN-STENT OCCLUSION IN THE MID LAD. THE LESION WAS WIRED AND PRE-DILATED WITH A 1.2X15MM NON-BSC, 2.0X12MM MAVERICK, AND 2.0X15MM NON-BSC BALLOONS. POBA WAS PERFORMED WITH A NON-BSC NC BALLOON WHICH RESTORED ADEQUATE FLOW. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016300 15048507

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention BALLOON CATHETER: 1.2X15MM - MINI TREK| BALLOON CATHETER: 2.0X15MM - MINI TREK| BALLOON CATHETER: 3.5X15MM SAPPHIRE NC| GUIDE CATHETER: XB 3.0 6FR| BALLOON CATHETER: 2.0X12MM MAVERICK| GUIDEWIRE: 0.014" BMW| GUIDEWIRE: 0.014" PILOT| GUIDEWIRE: 0.014" BMW