BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3052011 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00407
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS-EXCESSIVE FORCE WAS USED IN AN ATTEMPT TO ADVANCE THE DEVICE. INHERENT RISK OF PROCEDURE-STENT EMBOLISM. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-STENT DISLODGEMENT MOST LIKELY OCCURRED DUE TO THE SEVERE CALCIFICATION AND TORTUOUS NATURE OF THE VESSEL. USER/DEVICE INTERFACE -EXCESSIVE FORCE WAS USED IN AN ATTEMPT TO ADVANCE THE DEVICE. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT EMBOLISM. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-STENT DISLODGEMENT MOST LIKELY OCCURRED DUE TO THE SEVERE CALCIFICATION AND TORTUOUS NATURE OF THE VESSEL. USER ERROR CONTRIBUTED TO EVENT-EXCESSIVE FORCE WAS USED IN AN ATTEMPT TO ADVANCE THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE STENT WAS RETURNED ATTACHED TO A SNARE DEVICE. THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THERE WERE SIX SEGMENTS AT ONE END OF THE STENT STILL INTACT. THE REMAINING SEGMENTS WERE SEVERELY STRETCHED AND DEFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION IN A VESSEL THAT WAS HEAVILY CALCIFIED. THE STENT GOT CAUGHT ON THE CALCIFICATION WHILST BEING ADVANCED RESULTING IN DISLODGEMENT IN THE DISTAL LEFT MAIN/PROXIMAL CIRCUMFLEX. THE STENT WAS SNARED AND REMOVED. PATIENT IS STABLE WITH NO INJURY. THE PHYSICIAN ACKNOWLEDGED THAT THE DEFORMATION AND DISLODGEMENT WAS DUE TO THE CALCIFICATION AND SHAPE OF THE VESSEL (SHARP TAKE OFF OF CIRCUMFLEX FROM LEFT MAIN), AS WELL AS EXCESSIVE FORCE USED. HE DID NOT FEEL THAT THERE WAS AN ISSUE WITH THE STENT .HE STATED, "IT WOULD HAVE HAPPENED NO MATTER WHAT STENT WAS USED." CALCIFIED LESION WAS NOT STENTED, BUT OTHER AREA OF THE VESSEL WAS STENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154193 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006184195

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention