BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1222056 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01015
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (STENT DISLODGEMENT). SECONDARY INTERVENTION. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE FIRST THREE SEGMENTS ON ONE SIDE OF THE STENT APPEARED UNDAMAGED; THE REMAINING STENT SEGMENTS WERE DEFORMED AND BUNCHED. DUE TO THE SEVERITY OF THE DAMAGE TO THE STENT, IT WAS NOT POSSIBLE TO RECORD STENT OD'S. IT WAS ALSO NOT POSSIBLE TO CONFIRM THE NUMBER OF SEGMENTS OR STENT LENGTH AS MOST OF THE STENT SEGMENTS WERE DEFORMED AND BUNCHED. THE POSSIBILITY EXISTS THAT DURING THE PROCEDURE, THE BALLOON WAS INADVERTENTLY SUBJECTED TO A SLIGHT AMOUNT OF POSITIVE PRESSURE WHICH WOULD RESULT IN THE PROXIMAL SEGMENTS FLARING SLIGHTLY AS DESCRIBED IN THE EVENT DESCRIPTION, HOWEVER, THIS CANNOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THE PHYSICIAN 'PUSHED' THE STENT IN FURTHER AFTER IT WAS NOTED THAT THE PROXIMAL SEGMENTS HAD FLARED. IT APPEARS MOST LIKELY THAT THE FLARED PROXIMAL SEGMENTS MAY HAVE BEEN FURTHER DAMAGED WHEN FORCE WAS APPLIED IN ADVANCING THE STENT AND AS THE DAMAGED STENT WAS REMOVED PROXIMALLY FROM THE PATIENT, THE STENT SEGMENTS BUNCHED CATCHING IN THE INTRODUCER SHEATH AND DISLODGING AS REPORTED.

    Description of Event or Problem · 1

    A 2.75 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. LESION MORPHOLOGY WAS REPORTED 50% CALCIFIED WITH VESSEL TORTUOSITY MORE THAN 50%. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT WHEN THE STENT WAS ADVANCED TO THE LESION, THE STRUTS AT THE PROXIMAL PART OF THE STENT BECAME FLARED AND DETACHED BEFORE THE STENT WAS INFLATED. THE PHYSICIAN ATTEMPTED TO PUSH THE STENT FURTHER AND THE PROXIMAL PART OF THE STENT CRAMPED. THE PHYSICIAN EXPERIENCED DIFFICULTIES WHEN TRYING TO REMOVE THE STENT. THE STENT WAS UNABLE TO GO INTO THE GUIDE CATHETER; EVERYTHING WAS REMOVED AS A UNIT. THE STENT GOT STUCK IN THE INTRODUCER SHEATH; WHICH HAD TO BE CUT OPEN TO REMOVE THE STENT. IT IS UNKNOWN HOW THE LESION WAS TREATED. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000525684

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention