BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3200910 · Received July 2, 2013

    Report

    Report Number
    9612164-2013-00684
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 2, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT. PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-TOUGH, NASTY, CALCIFIED VESSELS. RELATED TO ANOTHER DEVICE-GUIDELINER HAS CONTRIBUTED TO THE DISLODGEMENT. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT. RELATED TO ANOTHER DEVICE-GUIDELINER HAS CONTRIBUTED TO THE DISLODGEMENT. LESION MORPHOLOGY-TOUGH, NASTY, CALCIFIED VESSELS. UNABLE TO CONFIRM COMPLAINT-DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE CIRCUMFLEX LESION WHICH EXHIBITED SHARP TURN OFF OF LM. THE VESSEL WAS REPORTED TO BE CALCIFIED AND TORTUOUS. NO ABNORMALITIES WERE NOTED DURING DEVICE PREPARATION. LESION WAS WIRED WITH A LONG WIRE, A 7FR. LAUNCHER GUIDE CATHETER WAS ALSO USED. LESION WAS PRE DILATED WITH DIFFICULTY WITH SPRINTER BALLOON. THE RESOLUTE STENT WOULD NOT CROSS; A GUIDELINER WAS PUT DOWN AND STENT ATTEMPTED AGAIN BUT STILL WOULD NOT CROSS. AS THE PHYSICIAN WAS PULLING THE STENT BACK IT DISLODGED FROM BALLOON CATHETER IN THE PROXIMAL CX. THE STENT WAS EVENTUALLY AFTER MANY ATTEMPTS RETRIEVED WITH A SNARE. THE STENT WAS STRETCHED AND DEFORMED. INFORMATION PROVIDED CONFIRMS THAT IT IS BELIEVED THAT THE GUIDELINER CONTRIBUTED TO THE STENT COMING OFF. DOCTOR STATED THAT THE STENT IS GOOD PRODUCT BUT JUST TOUGH, NASTY, CALCIFIED VESSELS. NO PATIENT COMPLICATION WAS REPORTED. NO CLINICAL SEQUELAE REPORTED. TARGET LESION WAS TREATED WITH ANOTHER RESOLUTE STENT.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE STENT WAS RETURNED ATTACHED TO A SNARE DEVICE AND A GUIDEWIRE. THE STENT WAS SEVERELY STRETCHED AND DEFORMED. THE DELIVERY SYSTEM WAS NOT RETURNED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303389 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006543542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention