BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2921601 · Received January 18, 2013

    Report

    Report Number
    9612164-2013-00085
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (DISSECTION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) - CALCIFICATION AT LESION. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) - CALCIFICATION AT LESION. INHERENT RISK OF PROCEDURE - (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN DEPLOYED ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT TO A MODERATE CALCIFIED LESION WITH 90% STENOSIS AT LAD WITH 14 ATM'S BUT THE BALLOON THEN RUPTURED. THE VESSEL AT THE EDGE OF THE STENT WAS RUPTURED AND THE PATIENT WHEN INTO CARDIOPULMONARY ARREST. CARDIAC MASSAGE AND CAGB WERE PERFORMED AND THE PATIENT RECOVERED. PHYSICIAN HAS INDICATED THAT THE EVENT WOULD HAVE BEEN IMPACTED BY CALCIFICATION AT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28049 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006230118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention