BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2944614 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00341
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT OCCURRED. THE PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE RIGHT CORONARY ARTERY. AFTER PRE-DILATION, A 4.0X16MM ION STENT WAS ADVANCED FOR TREATMENT, HOWEVER THE STENT CAME OFF THE DELIVERY BALLOON AND STAYED AT THE RIGHT CORONARY ARTERY UNDEPLOYED. NO ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. THE PHYSICIAN CHOSE TO SEND THE PATIENT FOR CABG SURGERY. IT WAS NOTED THAT THERE WERE NO PATIENT COMPLICATIONS OR RELATED TREATMENT AND IT WAS NOT DOCUMENTED THAT THE STENT WAS REMOVED FROM THE PATIENT. THE FINAL PATIENT STATUS WAS A SUCCESSFUL SINGLE VESSEL CABG.

    Description of Event or Problem · 1

    (B)(4). IT WAS FURTHER REPORTED THAT THE TARGET VESSEL WAS CALCIFIED AND TORTUOUS. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED 2.0X12MM BALLOON. THE 4.0X16MM ION STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION AND WHILE RETRIEVING THE DEVICE THE STENT DISLODGED AND STAYED WITHIN THE PROXIMAL CALCIFIED SECTION OF THE RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48934 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416400 14962574

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention