BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5906522 · Received August 26, 2016

    Report

    Report Number
    9612164-2016-00921
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    October 19, 2015
    Report Date
    July 29, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COM:(B)(4) "EXCESSIVE STENT OVERHANG AS AN UNCOMMON CAUSE OF VERY LATE STENT THROMBOSIS: USEFULNESS OF OPTICAL COHERENCE TOMOGRAPHY." INTERNATIONAL JOURNAL OF CARDIOLOGY 203 (2016) 123¿125 WWW.ELSEVIER .COM/LOCATE/IJCARD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RESOLUTE INTEGRITY RX DRUG ELUTING STENTS TO TREAT THREE LESIONS: 95% STENOSIS IN THE PROX LAD (3.0 X 28 MM), 80% STENOSIS IN THE PROX OBTUSE MARGINAL (2.75 X 18 MM) AND 95% STENOSIS IN THE OSTIUM AND PROX SEGMENT OF THE RAMUS INTERMEDIUS (RI) (3.0 X 30 MM). THE PATIENT SUFFERED AN MI APPROX 43 MONTHS POST INDEX PROCEDURE. THE PATIENT DISCONTINUED DAPT TREATMENT ONE WEEK PRIOR TO THE MI. ON INVESTIGATION, NO SIGNIFICANT RESTENOSIS, OR DE NOVO STENOSIS WAS OBSERVED. AN OCT REVEALED THE RI STENT STRUTS PROTRUDING IN THE LCX WITH ADHERENT THROMBOTIC MATERIAL BUT WITHOUT COMPLETE TISSUE COVERAGE LEADING TO SIGNIFICANT REDUCTION IN THE LUMINAL AREA AND RED THROMBUS. THE PHYSICIAN RESOLVED THE ISSUE WITH PCI BY PREDILATING THE AREA AND FINISHING WITH KISSING BALLOON INFLATION. THE POST-PCI OCT SHOWED LESS PROTRUSION OF THE STENT, AN IMPROVEMENT IN THE LUMINAL AREA AND RESIDUAL THROMBUS PERSISTENCE. NO FURTHER PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560211 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention