BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1850908 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01843
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: TORTUOUS VESSEL MORPHOLOGY. STENT CAME IN CONTACT WITH TIP OF GUIDE CATHETER. CONTRAVENING IFU AND USE OF FORCE. NO DEVICE RECEIVED FOR EVALUATION. CONCLUSIONS: TORTUOUS VESSEL MORPHOLOGY. CONTRAVENING IFU AND USE OF FORCE. STENT CAME IN CONTACT WITH TIP OF GUIDE CATHETER.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75MM DIAMETER X 12MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA. THE LESION WAS REPORTED TO EXHIBIT 70% STENOSIS WITH MODERATE TORTUOSITY AND CALCIFICATION. IT WAS REPORTED THAT FORCE WAS REQUIRED IN AN ATTEMPT TO ADVANCE THE DEVICE TOWARDS THE LESION. THE STENT SUBSEQUENTLY DISLODGED OFF THE BALLOON WHILE THE DEVICE WAS BEING PULLED BACK TOWARDS THE GUIDE CATHETER. THE PHYSICIAN REMOVED THE DISLODGED STENT USING A BALLOON. NO CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE EVALUATION: THE IMAGES SHOW THE PRESENCE OF DIFFUSE DISEASE THROUGHOUT THE RCA, WITH A NUMBER OF TORTUOUS BENDS IN THE VESSEL. THE DIFFICULT NATURE OF THE WIRE AND DEVICE DELIVERY CAN BE SEEN ON THE CINE IMAGES. NO IMAGES WERE PROVIDED SHOWING THE ATTEMPTED DELIVERY AND DISLODGEMENT OF THE ENDEAVOR RESOLUTE STENT. HOWEVER, A DISLODGED STENT IS CLEARLY EVIDENT IN THE PROXIMAL RCA. SUBSEQUENT IMAGES SHOW THE RETRIEVAL OF THE STENT FOLLOWED BY FURTHER BALLOONING AND PLACEMENT OF FOUR STENTS IN THE DISTAL, MID AND PROXIMAL VESSEL. THE FINAL ANGIOGRAPHIC IMAGE SHOWS GOOD FLOW IN THE VESSEL. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 201315969

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention