BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3081981 · Received April 29, 2013

    Report

    Report Number
    9612164-2013-00486
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (DISSECTION). CONCLUSIONS: INHERENT RISK OF PROCEDURE (DISSECTION). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD A RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE LAD AND IT WAS REPORTED THAT A DISSECTION OCCURRED. ANOTHER RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED AS TREATMENT IN THE LAD. IT WAS REPORTED THAT THIS EVENT WAS POSSIBLY RELATED TO THE DEVICE AND THE PATIENT RECOVERED WITH TREATMENT .

    Description of Event or Problem · 1

    CEC HAVE ADJUDICATED THAT THE PATIENT SUFFERED A NON Q WAVE MYOCARDIAL INFARCTION ON THE SAME DATE AS THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD A SUFFERED AN MI. THE PATIENT UNDERWENT REVASCULARIZATION OF THE RCA (NON TARGET VESSEL) AND ANGIOGRAPHY OF THE LAD ONE DAY POST MI. ONE RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA DURING THE REVASCULARIZATION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. PATIENT RECOVERED WITH TREATMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183889 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006126299

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention CLOPIDOGREL AND ASPIRIN.