BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 2831658 · Received November 14, 2012

    Report

    Report Number
    9612164-2012-01654
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE -DISSECTION IS LISTED IN THE SPRINTER LEGEND RX INSTRUCTIONS AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY BALLOON DEVICE. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED -DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE -DISSECTION IS LISTED IN THE SPRINTER LEGEND RX INSTRUCTIONS (IFU) AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY BALLOON DEVICE. UNABLE TO CONFIRM COMPLAINT -DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A SPRINTER LEGEND TO TREAT A LESION IN THE LAD WHICH WAS REPORTED TO EXHIBIT MODERATE TORTUOSITY AND WAS CALCIFIED. NO ABNORMALITIES WERE NOTICED DURING PREPARATION OF THE DEVICE. IT WAS REPORTED THAT FORCE WAS USED TO DELIVER THE DEVICE TO THE LESION. FOLLOWING INFLATION OF THE BALLOON AT THE LESION, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN ATTEMPTS TO DEFLATE THE BALLOON. MULTIPLE ATTEMPTS WERE MADE, INCLUDING OVER INFLATION, WITH NO SUCCESS. AN ATTEMPT WAS MADE TO ADVANCE THE GUIDE CATHETER INTO THE AREA TO EITHER CAPTURE THE BALLOON OR RUPTURE IT, HOWEVER, WAS ALSO UNSUCCESSFUL. FOLLOWING THIS, A DISSECTION WAS NOTICED IN THE LEFT MAIN ARTERY TO THE LEFT ARTERIAL DESCENDING. THE PHYSICIAN TREATED THE AREA WITH STENTS. THE INFLATED BALLOON WAS RETRIEVED BY BRINGING GUIDE TO THE LESION SITE WHERE THE BALLOON WAS INFLATED AND FORCEFULLY PULLED INTO 7F GUIDE. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Description of Event or Problem · 1

    IMAGE REVIEW: STILL IMAGES OF THE VESSEL PRE-TREATMENT, THE FIRST AND SECOND BALLOON INFLATIONS AND AN IMAGE CONFIRMING THE VESSEL DISSECTION WERE PROVIDED FROM THE FIELD. THE IMAGES CONFIRM THE TORTUOUS CALCIFIED NATURE OF THE LAD. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DEFLATION DIFFICULTIES OR THE ROOT CAUSE OF THE DISSECTION FROM THE PROCEDURAL IMAGES PROVIDED. THE IMAGES OF THE DEVICE PROVIDED FROM THE FIELD APPEAR TO SHOW THAT THE DISTAL INFLATION LUMEN/BALLOON BOND AND THE TRANSITION TUBING ARE NECKED/STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 206108508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention