BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2982960 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01045
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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 MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR#2134265-2013-01046. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT EXPLANTATION OCCURRED. THE TARGET LESION WAS IN THE PROXIMAL TO DISTAL DIAGONAL (DIAG) CORONARY ARTERY. THE PHYSICIAN DEPLOYED THE 1ST ION STENT IN THE PROXIMAL DIAG ARTERY, AND IT WAS WELL POSITIONED AND WELL APPOSED. THE 2ND ION STENT WAS NOTED TO HAVE DISTAL STENT DAMAGE, WHEN IT WAS BEING REMOVED FROM THE PACKAGING, WHICH THE PHYSICIAN CRIMPED DOWN. THE PHYSICIAN ADVANCED THIS STENT TO THE DISTAL DIAG AND THE STENT GOT CAUGHT ON THE 1ST IMPLANTED STENT. DURING REMOVAL OF THE SECOND STENT THE FIRST STENT WAS EXPLANTED. THE 1ST STENT WAS NOTED TO BE ELONGATED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH 2 MORE IONN STENTS IN THE LEFT ANTERIOR DESCENDING ARTERY, AND 2 MORE ION STENTS IN THE DIAG. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR#2134265-2013-01046. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT EXPLANTATION OCCURRED. THE TARGET LESION WAS IN THE PROXIMAL TO DISTAL DIAGONAL (DIAG) CORONARY ARTERY. THE PHYSICIAN DEPLOYED THE 1ST ION STENT IN THE PROXIMAL DIAG ARTERY, AND IT WAS WELL POSITIONED AND WELL APPOSED. THE 2ND ION STENT WAS NOTED TO HAVE DISTAL STENT DAMAGE, WHEN IT WAS BEING REMOVED FROM THE PACKAGING, WHICH THE PHYSICIAN CRIMPED DOWN. THE PHYSICIAN ADVANCED THIS STENT TO THE DISTAL DIAG AND THE STENT GOT CAUGHT ON THE 1ST IMPLANTED STENT. DURING REMOVAL OF THE SECOND STENT THE FIRST STENT WAS EXPLANTED. THE 1ST STENT WAS NOTED TO BE ELONGATED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH 2 MORE ION STENTS IN THE LEFT ANTERIOR DESCENDING ARTERY, AND 2 MORE ION STENTS IN THE DIAG. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85885 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902324220 15222713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention