BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3791900 · Received May 6, 2014

    Report

    Report Number
    9612164-2014-00497
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    May 15, 2013
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT THROMBOSIS). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (STENT THROMBOSIS). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (THROMBOSIS). (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 ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT DEPLOYED AT THE RPL . APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED STENT THROMBOSIS IN THE TERRITORY OF THE TARGET VESSEL. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH THE STUDY DEVICE. ON THE SAME DAY, POST THE STENT THROMBOSIS EVENT, THE RPL WAS REVASCULARIZED WITH ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT DUE TO STENOSIS AND UNSTABLE ANGINA. THE INVESTIGATOR ASSESSED THAT THE REVASCULARIZATION EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE EVENT WAS RESOLVED. THE PATIENT SUFFERED IN-STENT RESTENOSIS AND UNDERWENT TARGET VESSEL REVASCULARIZATION OF THE RPL WITH AN UNKNOWN BRAND STENT APPROX 9 MONTHS POST INDEX PROCEDURE. THE INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    A NON MDT STENT WAS USED DURING THE PREVIOUSLY REPORTED REVASCULARIZATION OF THE RPL APPROX 9 MONTHS POST INDEX PROCEDURE. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A MI.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THE PREVIOUSLY REPORTED STENT THROMBOSIS EVENTS 16 AND 18 MONTHS POST INDEX PROCEDURE TO BE DEFINITELY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED STENT THROMBOSIS EVENT OCCURRING APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE OCCURRED ON (B)(6) 2013 AND NOT ON THE (B)(6) 2013 AS PREVIOUSLY REPORTED

    Description of Event or Problem · 1

    APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED UNSTABLE ANGINA. THE PATIENT HAD AN ANGIOGRAPHY ONE DAY LATER REVEALING STENT THROMBOSIS WITHIN THE TARGET VESSEL. BALLOON ANGIOPLASTY WAS CARRIED OUT AS TREATMENT. PATIENT REPORTED TO HAVE RECOVERED WITH TREATMENT. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED ACUTE CORONARY SYNDROME. THE PATIENT HAD AN ANGIOGRAPHY ONE DAY LATER REVEALING STENT THROMBOSIS WITHIN THE TARGET VESSEL. BALLOON ANGIOPLASTY WAS CARRIED OUT AS TREATMENT. PATIENT REPORTED TO HAVE RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THE PREVIOUSLY REPORTED STENT THROMBOSIS EVENT APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE AS DEFINITELY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272586 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006392194

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R ASPIRIN, CLOPIDOGREL| CLOPIDOGREL AND ASPIRIN.