BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3220604 · Received July 11, 2013

    Report

    Report Number
    9612164-2013-00705
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (UNKNOWN) ¿ ROOT CAUSE IS UNDETERMINED. (INHERENT RISK OF PROCEDURE) ¿ ALLERGIC REACTION. (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED)- NO PRODUCT RETURNED. EVALUATION CONCLUSION: (INHERENT RISK OF PROCEDURE) - ALLERGIC REACTION IS LISTED IN THE PRODUCT IFU AS AN INHERENT RISK OF CORONARY STENTING PROCEDURES. (UNABLE TO CONFIRM COMPLAINT).-NO PRODUCT RETURNED. (UNKNOWN) - ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    PATIENT HAD A NON-MEDTRONIC STENT IMPLANTED IN THE DISTAL RCA. APPROXIMATELY 13 MONTHS LATER, PATIENT HAD TWO RESOLUTE INTEGRITY STENTS IMPLANTED IN THE RCA. THE DEVICES WERE IMPLANTED SUCCESSFULLY. DAYS AFTER THIS THE PATIENT BEGAN EXPERIENCING ALLERGIC REACTIONS (HIVES, FACE AND TONGUE SWELLS WHERE AN EPINEPHRINE PEN WAS USED AND HOSPITALIZED TWICE). PATIENT HAD AN ALLERGY TEST THAT RETURNED INCONCLUSIVE. AS SYMPTOMS STARTED AFTER THE MEDTRONIC STENTS WERE IMPLANTED, PATIENT THINKS THAT IT IS PROBABLE THAT THE TWO ARE LINKED. IT IS REPORTED THAT APPROXIMATELY 3 MONTHS POST STENT IMPLANT, PATIENT SUFFERED AN IN STENT RESTENOSIS OF THE 2.25X30 MM RESOLUTE INTEGRITY STENT. A NON-MEDTRONIC STENT WAS USED IN THE REVASCULARIZATION. THE PHYSICIAN CONFIRMED THE OTHER RESOLUTE INTEGRITY STENT WAS FINE. PHYSICIAN HAD NO QUESTIONS OR CONCERNS ABOUT THE RESOLUTE INTEGRITY PERFORMANCE. PATIENT IS NOW ON A NEW DRUG WHICH IS WORKING ON THE ITCH AND THE HIVES ARE REPORTED TO BE MUCH LESS TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320243 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006015856

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R