BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1820073 · Received August 24, 2010

    Report

    Report Number
    2953200-2010-01616
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD & RESULTS: X-RAY, FLUOROSCOPY, IVUS, CT, MRI ETC., HIGHLY CALCIFIED LESION, FAILURE TO DELIVER THE STENT. CONCLUSIONS: HIGHLY CALCIFIED LESION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO A HIGHLY CALCIFIED LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. IT WAS REPORTED THAT THE ATTEMPT TO CROSS THE LESION WAS UNSUCCESSFUL AND THE DEVICE WAS REMOVED. UPON REMOVAL IT WAS NOTED THAT THE STENT WAS DAMAGED. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. THE FIRST 7 DISTAL SEGMENTS WERE IN PLACE AND UNDAMAGED. THE MIDDLE AND PROXIMAL SEGMENTS WERE STRETCHED AND DEFORMED. NO FURTHER DAMAGE WAS NOTED. CINE IMAGE REVIEW: PROCEDURAL CD IMAGES WERE PROVIDED FOR EVALUATION. THE IMAGES SHOWED THAT THE TARGET LESION WAS LOCATED IN THE MID RCA AND WAS AN INSTENT-RESTENOSIS. FROM THE IMAGES THERE APPEARS TO BE DIFFICULTY DURING DELIVERY OF THE WIRE. THERE ARE NO IMAGES OF STENT DEPLOYMENT. THE IMAGES DO SHOW SEVERAL PRE-DILATION ATTEMPTS. THE CAG AFTER THE FIRST PRE-DILATION SHOWS A SIGNIFICANT AMOUNT OF DIFFUSE DISEASE STILL PRESENT IN THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002269587

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK