BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160590 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00676
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (NINETY PERCENT STENOSIS, MODERATE TORTUOSITY/CALCIFICATION). (FAILURE TO DELIVER STENT/STENT EMBOLISM). CONCLUSIONS: (NINETY PERCENT STENOSIS, MODERATE TORTUOSITY/CALCIFICATION). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THE STENT WAS RETURNED FOR EVALUATION. ALL THE STENT SEGMENTS WERE RAISED, STRETCHED, DAMAGED AND DEFORMED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS BEEN USED FOR TREATMENT OF A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA), POSTERIOR DESCENDING ARTERY (PDA). THE LESION WAS NINETY PERCENT STENOSED WITH MODERATE TORTUOSITY AND CALCIFICATION. THE PHYSICIAN ADVANCED THE ENDEAVOR SPRINT RX BUT IT COULD NOT ADVANCE TO THE PDA AND WHEN THE PHYSICIAN PULLED BACK THE DEVICE, THE STENT CAME OFF THE BALLOON. A PTCA BALLOON CATHETER WAS INSERTED TO THE DISLODGED STENT AND THE STENT WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE LESION WAS PRE-DILATED PRIOR TO ATTEMPTED USE OF THE ENDEAVOR SPRINT RX STENT. THE DEVICE WAS PREPPED BEFORE USE WITH NO ISSUES NOTED. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005482255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention