BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX CORNARY STENT SYSTEM

    MDR report key: 2201799 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00880
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: METHOD: FILM (X-RAY, FLUOROSCOPY, IVUS, CT, MRI, ETC). EVAL: RESULTS: (PT LESION MORPHOLOGY AT THE SITE OF THE REPORTED FRACTURE), (STENT DEFORMATION). EVAL: CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (PT LESION MORPHOLOGY AT THE SITE OF THE REPORTED FRACTURE). EVAL SUMMARY: THE DEVICE CATHETER WAS RETURNED FOR EVAL; HOWEVER, THE STENT WAS NOT PRESENT. THERE WAS NO DAMAGE PRESENT ON THE BALLOON OF THE DEVICE THAT COULD HAVE IMPACTED THE DEPLOYMENT OF THE STENT. CINE IMAGE EVALUATION: PROCEDURAL IMAGES CONFIRM THAT THE VESSEL WAS TORTUOUS AND CALCIFIED. DISTORTION OF THE STENT POST DILATION WAS EVIDENT FROM THE IMAGES AND THE DEPLOYMENT OF ANOTHER ENDEAVOR RESOLUTE STENT WAS ALSO VISIBLE; HOWEVER, THIS WAS UNSUCCESSFUL IN BRIDGING THE DISTORTION. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED A 3.0 MM DIAMETER X 18MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OSTIAL RCA WITH THE PRESENCE OF CALCIFICATION. WHEN THE PHYSICIAN POST DILATED THE STENT AFTER ITS IMPLANTATION, IT WAS REPORTED THAT THE STENT FRACTURED. ANOTHER ENDEAVOR RESOLUTE STENT WAS USED AND IMPLANTED IN THE VESSEL. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORNARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005625167

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention