BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4162073 · Received October 10, 2014

    Report

    Report Number
    9612164-2014-01312
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: (DISSECTION, FAILURE TO DELIVER THE STENT AND EMBOLISM). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED).- DEVICE NOT PROVIDED FOR REVIEW. RELATED TO OPERATIONAL CONTEXT ¿ COMPLEXITY OF THE CASE AND MULTIPLE PASSES THROUGH A NEWLY DEPLOYED STENT. (NONE). ¿ DEVICE NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS USED TO TREAT A LESION IN THE MID RCA. THE LESION WAS 95% STENOSED, CALCIFIED AND DISEASED. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED NO ISSUES NOTED. AN ATTEMPT WAS MADE TO DELIVER THE DEVICE BUT THIS WAS UNSUCCESSFUL. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS REMOVED AND A SECOND ATTEMPT WAS MADE USING A GUIDELINER FOR SUPPORT. DURING ADVANCEMENT THE STENT GOT CAUGHT GOING THROUGH A PREVIOUSLY DEPLOYED STENT AND DURING AN ATTEMPT TO REMOVE THE DEVICE THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A LOCALIZED DISSECTION OCCURRED AT THE DISTAL LESION BUT THERE APPEARS TO BE GOOD ANTEGRADE FLOW. THE PHYSICIAN INDICATED THAT THE DISSECTION WAS CAUSED BY TRYING TO DELIVER THE DEVICE TO THE DISTAL TARGET LESION. A NON COMPLIANT BALLOON WAS USED TO CRUSH THE STENT INTO THE VESSEL WALL. THE PATIENT IS REPORTED TO BE FINE POST PROCEDURE. THE PHYSICIAN AGREES THAT THE COMPLEXITY OF THE CASE AND MULTIPLE PASSES THROUGH A NEWLY DEPLOYED STENT THAT THIS A PROCEDURAL RELATED EVENT AND NOT A PRODUCT FAILURE. IMAGE REVIEW IT APPEARS THAT THE INNER LUMEN OF THE VESSEL AT THE LEVEL OF THE NEWLY DEPLOYED STENT IN THE MID RCA MAY NOT HAVE BEEN CONCENTRIC AND THE IRREGULARITY OF THE LUMEN MAY HAVE RESULTED IN DAMAGE TO THE 2.25 X 8MM RESOLUTE INTEGRITY STENT DURING DELIVERY, CAUSING IT TO GET CAUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643441 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007220078

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention