BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2230836 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01030
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (STENT PROFILE BECAME DISTORTED IN A COMPLEX LESION, LESION WAS A CHRONIC TOTAL OCCLUSION (CTO)). CONCLUSION: (STENT PROFILE BECAME DISTORTED IN A COMPLEX LESION, LESION WAS A CHRONIC TOTAL OCCLUSION (CTO)).

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED 2.75 MM DIAMETER X 30MM LENGTH INTEGRITY RAPID EXCHANGE (RX) BARE METAL STENT TO TREAT A CTO (CHRONIC TOTAL OCCLUSION) LESION. PRIOR TO THE STENT DEPLOYMENT, THE LESION WAS PRE-DILATED AND 30% STENOSIS REMAINED. THE PHYSICIAN ALSO DEPLOYED ANOTHER INTEGRITY STENT PROXIMALLY TO THE INITIAL STENT. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS EXAMINING THE IVUS IMAGES, HE NOTICED A FILLING DEFECT IN THE PROXIMAL SEGMENT OF THE DISTAL INTEGRITY STENT, WHICH THE PHYSICIAN BELIEVED TO BE A STENT FRACTURE AND/OR MALPOSITION OF THE STENT. ANOTHER BARE METAL STENT WAS IMPLANTED TO TREAT THE REPORTED STENT FRACTURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention