BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8360932 · Received February 22, 2019

    Report

    Report Number
    9612164-2019-00597
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    February 7, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT HISTORY: FORMER SMOKER, DIABETES, HYPERCHOLESTEREMIA, HYPERTENSION, PRIOR TIA¿S. THE PATIENT PRESENTED WITH PALPITATIONS, SOB, ANTERIOR ISCHEMIA AND 3 VESSEL DISEASE. ADDITIONAL INFORMATION: THE LCX HAD 95% STENOSIS. THE 2.5X15MM RESOLUTE ONYX WAS DEPLOYED IN THE MID RCA WITH ONE INFLATION OF 14 ATM (MAX). THE STENT WAS P OST-DILATED THREE TIMES TO 16 ATM (MAX). THE PCI OF THE MID RCA WAS SUCCESSFUL, WITH RESIDUAL STENOSIS OF 0%, EXCELLENT ANGIOGRAPHIC APPEARANCE, AND TIMI FLOW 3. THE 2.75X15MM RESOLUTE ONYX WAS DEPLOYED IN THE MID LAD WITH ONE INFLATION TO A PRESSURE OF 10 ATM (MAX). THE STENT WAS POST DILATED WITH 2 INFLATIONS TO 14 ATM (MAX). THE PCI OF THE MID LAD WAS SUCCESSFUL, WITH RESIDUAL STENOSIS OF 0%, EXCELLENT ANGIOGRAPHIC APPEARANCE, AND TIMI FLOW 3. THERE WERE NO ISSUES DURING STENT DEPLOYMENT. BOTH STENTS WERE FULLY DEPLOYED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS RECOMMENDED FOR LIFELONG ASA AND DAILY 75MG OF PLAVIX FOR AT LEAST ONE YEAR. PREVIOUSLY REPORTED STENT THROMBOSIS WAS SUBACUTE. THERE WAS A RADIAL APPROACH FOR STEMI. TO TREAT THE THROMBUS, THE RCA WAS STENTED WITH 2 STENTS OVERLAPPING PROXIMALLY AND DISTALLY. THE LAD WAS STENTED PROXIMAL TO DISTAL WITH OVERLAPPING STENTS. THE PATIENT ON DAPT WHEN THE THROMBOTIC EVENT OCCURRED. THE PATIENT'S ANTI-PLATELET MEDICATION WAS CHANGED DUE TO SUSPECTED RESISTANCE TO THE FIRST MEDICATION THAT WAS ADMINISTERED. THE PATIENT WAS REPORTED TO BE DOING FINE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CINE IMAGE EVALUATION: THE IMAGES CAPTURE A LESION SITE IN THE MID RCA AS REPORTED. THE PRE-DILATION OF THE LESION SITE IS EVIDENT. THE IMAGES THEN CAPTURE THE DEPLOYMENT OF THE RESOLUTE ONYX STENT IN THE MID RCA. A DENT LIKE APPEARANCE IN THE STENT PROFILE SUGGESTS THE STENT IS CONFORMING TO THE TORTUOSITY AND CALCIFICATION OF THE LESION SITE. POST DILATION OF THE STENT IS VISIBLE FROM THE IMAGES WITH UNIDENTIFIED BALLOON DEVICES. THERE IS NO EVIDENCE OF THROMBUS IN THE STENT AFTER INITIAL IMPLANT. THE IMAGES THEN CAPTURE A LESION SITE IN THE LAD AS REPORTED. DIRECT STENTING IS CARRIED OUT WITH THE SECOND RESOLUTE ONYX STENT. POST DILATION OF THE STENT IS VISIBLE FROM THE IMAGES. THERE IS NO EVIDENCE OF THROMBUS IN THE STENT AFTER INITIAL IMPLANT. THE IMAGES THEN CAPTURE THE RCA THREE DAYS POST INDEX PROCEDURE. THROMBOSIS IS EVIDENT AT THE SITE OF THE PREVIOUSLY DEPLOYED RESOLUTE ONYX STENT. POST DILATION OF THE STENT IS VISIBLE, AFTER WHICH BLOOD FLOW IS RESTORED IN THE VESSEL. STENTS ARE DEPLOYED DISTAL AND PROXIMAL TO THE PREVIOUSLY DEPLOYED RESOLUTE ONYX STENT, AND FURTHER POST DILATION OF THE STENTS IS VISIBLE. THERE WAS NO EVIDENCE OF THROMBUS IN THE RCA POST PCI. THE IMAGES THEN SHOW THE LAD THREE DAYS POST INDEX PROCEDURE, WITH THROMBOSIS EVIDENT AT THE SITE OF THE DEPLOYED RESOLUTE ONYX STENT. POST DILATION OF THE STENT IS EVIDENT, AFTER WHICH BLOOD FLOW IS RESTORED IN THE VESSEL. STENTS ARE THEN DEPLOYED DISTAL AND PROXIMAL TO THE PREVIOUSLY DEPLOYED RESOLUTE ONYX STENT, AND POST DILATION OF THE STENTS IS VISIBLE FROM THE IMAGES. THERE WAS NO EVIDENCE OF THROMBUS IN THE LAD POST PCI. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A PROCEDURE ONE 2.5X15MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID RCA AND ONE 2.75X15MM RESOLUTE ONYX DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE MID LAD. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. BOTH LESIONS WERE PRE-DILATED. NEITHER DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHILE ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. ITWAS REPORTED THAT STENT THROMBOSIS OCCURRED IN BOTH RESOLUTE ONYX STENTS BETWEEN 24HOURS AND 30 DAYS POST IMPLANTATION. THE PATIENT IS REPORTED TO BE ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154675 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009303765

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention