BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC SPRINTER RX

    MDR report key: 2880886 · Received December 20, 2012

    Report

    Report Number
    9612164-2012-01812
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 18, 2012
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-CHRONIC TOTAL OCCLUSION. EVALUATION CONCLUSION: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-CHRONIC TOTAL OCCLUSION.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-DISSECTION. DEFORMATION PROBLEM. RELATED TO OPERATIONAL CONTEXT - THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED. CONCLUSION: INHERENT RISK OF PROCEDURE - DISSECTION. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT - THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CASE INVOLVED LESION IN PROXIMAL LAD WHICH WAS REPORTED TO BE A CHRONIC TOTAL OCCLUSION WHICH WAS PRE-DILATED. CINE IMAGE REVIEW: CINE IMAGES PROVIDED SHOW THE STENT IS NOT FULLY OPENED AT PROXIMAL END EVEN DURING INFLATION, SUGGESTING THE LESION MORPHOLOGY LEAD TO DIFFICULTY IN DILATING THE LESION IN THIS REGION.

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN THEN USED A NC SPRINTER BALLOON. ON THE 3RD INFLATION AT 18ATM, THE BALLOON BURST. DIFFICULTY WAS ENCOUNTERED DURING ATTEMPTS TO REMOVE THE BALLOON AND A DETACHMENT OCCURRED. A SNARE WAS USED TO REMOVE THE PRODUCT. DURING INTERVENTION THE PATIENT EXPERIENCED A LEFT MAIN DISSECTION. TWO DAYS LATER AN IMPELLA DEVICE WAS USED TO STENT THE LEFT MAIN. AS OF THE INCIDENT REPORT, THE PATIENT WAS ON A BALLOON PUMP AND BEING CONSIDERED FOR STEM CELL THERAPY. EVALUATION SUMMARY: THE BALLOON HAD DETACHED RADIALLY AT THE PROXIMAL BALLOON CONE. THE TIP HAD DETACHED AT THE TIP SEAL BOND. THE DETACHMENTS WERE JAGGED IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 12428602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention