BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160961 · Received June 16, 2011

    Report

    Report Number
    9612164-2011-00583
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVAL, RESULTS: (SEVERELY CALCIFIED TORTUOUS LESION. FAILURE TO DELIVER THE STENT. EVAL CODES, CONCLUSION: SEVERELY CALCIFIED TORTUOUS LESION). (FAILURE TO DELIVER THE STENT). CONCLUSION: (SEVERELY CALCIFIED TORTUOUS LESION). EVAL SUMMARY: THE DEVICE WAS RETURNED. THE HYPOTUBE WAS BENT. THE STENT HAD MOVED DISTALLY ALONG THE BALLOON WITH 13 SEGMENTS LOCATED DISTAL TO THE DISTAL TIP. THE FIRST THREE PROXIMAL AND FIRST TWO DISTAL STENT SEGMENTS WERE RELATIVELY INTACT, THE REMAINING MIDDLE SEGMENTS WERE SEVERELY STRETCHED. THE FIRST, SECOND AND THIRD PROXIMAL STENT SEGMENTS WERE POSITIONED ON THE BALLOON. THE REST OF SEGMENTS WERE OFF THE BALLOON, DAMAGED AND DEFORMED. CRIMP IMPRESSIONS WERE EVIDENT ON THE BALLOON. A PROTECTIVE SHEATH COULD NOT BE PLACED OVER THE STENT DUE TO THE SEVERE STRETCHING. THE PROXIMAL STENT OD MET SPECIFICATIONS. IT WAS NOT POSSIBLE TO TAKE MIDDLE AND DISTAL STENT OD MEASUREMENTS DUE TO THE STENT DAMAGE.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN ENDEAVOR SPRINT RAPID EXCHANGE CORONARY STENT SYSTEM DIAMETER 2.5MM LENGTH 24MM TO TREAT A SEVERELY CALCIFIED TORTUOUS LESION IN THE LAD. WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE LESION, THE DEVICE GOT STUCK AT THE CALCIFIED LESION. IT WAS NOT POSSIBLE TO ADVANCE IT FURTHER THAN THE TIP OF THE CATHETERS. THE PHYSICIAN THEN WITHDREW THE DEVICE WITHOUT ANY RESISTANCE AND FOUND THAT THE STENT WAS STRETCHED. THE PHYSICIAN SUBSEQUENTLY PREDILATED THE LESION AND DEPLOYED A NON-MEDTRONIC STENT TO TREAT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002074306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK