BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2832415 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06850
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 MED WATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS 2134265-2012-06843 AND 2134265-2012-06844. IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE NO FLOW OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO AN ACUTE MI OF THE RIGHT CORONARY ARTERY (RCA). TWO UNSPECIFIED GUIDE WIRES WERE PLACED AND THE VESSEL WAS BALLOONED WITH AN UNKNOWN BALLOON CATHETER. ACTIVE CLOT WAS NOTED IN THE RCA. SOME OF THE CLOT WAS ABLE TO BE REMOVED WITH A NON-BSC THROMBECTOMY CATHETER. ANGIOGRAPHIC IMAGES REVEALED THERE WAS STILL THROMBUS NOTED N THE LESION. A 4.0X32MM ION DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID TO DISTAL RCA; HOWEVER, NO FLOW WAS NOTED IN THE VESSEL. A SECOND ION DES WAS IMPLANTED PROXIMAL TO THE 1ST DES IN THE MID RCA AND STILL, NO FLOW PERSISTED IN THE VESSEL. A 3RD ION DES WAS IMPLANTED PROXIMAL TO THE 2ND DES IN THE PROXIMAL RCA WITH NO FLOW CONTINUING IN THE VESSEL. THE PATIENT WAS SENT TO SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420400 14312866

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention