BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2973588 · Received February 22, 2013

    Report

    Report Number
    9612164-2013-00201
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ROOT CAUSE OF DISLODGEMENT IS UNDETERMINED. STENT DISLODGEMENT. STENT WAS FLATTENED AND DEFORMED. CONCLUSION: STENT DISLODGEMENT. ROOT CAUSE OF DISLODGEMENT IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE DISTAL LMCA WHICH WAS REPORTED TO 'HAZY WITH A POSSIBLE DISRUPTION OF PLAQUE." NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE. DURING ATTEMPTED DELIVERY THE STENT DISLODGED FROM THE BALLOON AND WAS REMOVED WITH A SNARE. PATIENT IS STABLE. EVALUATION SUMMARY: THE STENT AND DELIVERY SYSTEM WERE RETURNED. THE STENT WAS RETURNED ATTACHED TO A SNARE DEVICE. THE STENT WAS FLATTENED AND DEFORMED. CRIMP IMPRESSIONS WERE EVIDENT ALONG THE BALLOON. IMAGE REVIEW IMAGES CONFIRM THE PRESENCE OF DIFFUSE DISEASE IN THE LCAS. THE TARGET LESION WAS PRE-DILATED FOLLOWED BY THE DEPLOYMENT OF A LONG STENT. A DISLODGED STENT WAS DETECTED ON THE WIRE IN THE LMCA. NO IMAGES WERE PROVIDED SHOWING THE DELIVERY OF THE STENT DELIVERY CATHETER OR OF ANY DIFFICULTIES THAT COULD HAVE IMPACTED ON THE SUBSEQUENT DISLODGEMENT. THE SNARING OF THE STENT WAS NOT SHOWN ON THE IMAGES PROVIDED. THE IMAGES DID NOT PROVIDE ANY INSIGHT INTO THE ROOT CAUSE OF THE DISLODGEMENT. THE PROCEDURAL WIRE DOES APPEAR TO HAVE COILED AND BUNCHED WITHIN THE ORIGINALLY DEPLOYED STENT IN THE VESSEL. THIS DID NOT APPEAR TO BE RELATED TO THE RESOLUTE INTEGRITY STENT DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78618 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006120228

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention