BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1760944 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01318
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    MEDTRONIC CARIDOVASCULAR GALWAY
    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: INCORRECT REMOVAL OF PROTECTIVE SHEATH. CONCLUSION: INCORRECT REMOVAL OF PROTECTIVE SHEATH. EVAL SUMMARY: MEDTRONIC HAS REC'D THE RELEVANT STENT AND ITS ANALYSIS HAS BEEN COMPLETED. CRIMP/BAKE IMPRESSIONS WERE EVIDENT ON THE INFLATED BALLOON. THE STENT AND THE SHEATH WERE STILL ON THE STYLETTE. THE FIRST THREE DISTAL AND FIRST FOUR PROXIMAL STENT SEGMENTS WERE STILL INTACT. THE REMAINING SEGMENTS WERE STRETCHED AND DEFORMED. NO ABNORMALITIES WERE FOUND ON THE PROTECTIVE SHEATH.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.5MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN A PT. HOWEVER, IT WAS REPORTED THAT ON INFLATION OF THE BALLOON, IVUS CONFIRMED THAT THERE WAS NO STENT ON THE BALLOON OF THE DELIVERY SYSTEM. THE STENT WAS FOUND WITH THE PROTECTIVE SHEATH ON THE TRAY. THE PT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX NIQ MEDTRONIC CARIDOVASCULAR GALWAY NA 0001850633

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK