BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6796553 · Received August 16, 2017

    Report

    Report Number
    9612164-2017-01113
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 18, 2016
    Report Date
    July 18, 2017
    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

    (B)(4). JOURNAL ARTICLE: DOI: 10.1007/S12928-016-0413-1.

    Description of Event or Problem · 1

    A CORONARY ANGIOGRAPHY SHOWED SEVERE STENOSIS IN THE CORONARY TREE. PCI TO THE LCX WAS PERFORMED. A 3.0X38MM RESOLUTE INTEGRITY STENT WAS DEPLOYED. A FEW DAYS LATER DURING REHABILITATION, THE PATIENT COMPLAINED OF SLIGHT CHEST PAIN AND AN ECG REVEALED A DEEP DEPRESSION OF THE ST SEGMENT. FOLLOWING CONFIRMATION OF NO STENT THROMBOSIS IN THE IMPLANTED STENT IN THE LCX, FFR MEASUREMENT OF A LESION IN THE RCA WAS PERFORMED. FFR MEASUREMENT OF A LESION IN THE LAD WAS ATTEMPTED BUT WIRING OF THE LESION WITH A PRESSURE WIRE WAS DIFFICULT DUE TO THE SEVERITY OF THE LESION. A PCI TO THE LAD AT THE BIFURCATION POINT WITH SEVERE STENOSIS OF THE DIAGONAL BRANCH WAS THEN PERFORMED, FOUR DAYS AFTER THE INITIAL PCI. THERE WAS SEVERE STENOSIS JUST DISTAL OF THE DIAGONAL BRANCH IN THE MV; THEREFORE, THE FORMATION OF STENOSIS AT THE OSTIUM OF THE DIAGONAL BRANCH WAS EXPECTED DUE TO PLAQUE SHIFT. AN IVUS CATHETER WAS ADVANCED TO THE DISTAL LAD. THE IVUS SHOWED AN ECCENTRIC FIBROUS PLAQUE IN THE LESION. A 3.5X18MM RESOLUTE INTEGRITY STENT WAS DEPLOYED AT 9ATM IN THE MV WITH PRESSURE WIRE IN THE DIAGONAL BRANCH JAILED BY THE STENT. FOLLOWING POST-DILATATION AT 18ATM, IVUS WAS PERFORMED. IT REVEALED A MALAPPOSITION OF THE STENT AND ADDITIONAL DILATATION WAS PERFORMED WITH A NON MDT BALLOON AT 18ATM. A FINAL CAG REVEALED A WELL-DILATED MV AND PRESERVED DIAGONAL BRANCH FLOW. THE PATIENT'S CHEST PAIN DISAPPEARED AFTER THE PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576825 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention