BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7243628 · Received February 6, 2018

    Report

    Report Number
    9612164-2018-00208
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    December 14, 2017
    Report Date
    February 6, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: DOI:10.1136/BCR-2017-222481. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS REFERRED TO A PERIPHERAL HOSPITAL FOR CORONARY ANGIOGRAPHY DUE TO A SUBACUTE NSTEMI. INITIALLY THE PATIENT PRESENTED 7 DAYS PREVIOUSLY COMPLAINING OF RETROSTERNAL CHEST PAIN AND WAS DIAGNOSED AS SUFFERING FROM BRONCHITIS. CHEST PAIN CONTINUED AND THE PATIENT EXPERIENCED A 5KG WEIGHT GAIN AND THEREFORE PRESENTED TO EMERGENCY ON WEEK LATER. AUSCULTATION REVEALED BILATERAL BASAL CREPITATIONS, WITH BILATERAL LEG OEDEMA CONSISTENT WITH DECOMPENSATED HEART FAILURE. THE PATIENT WAS DIAGNOSED WITH NEW ONSET PAROXYSMAL ATRIAL FIBRILLATION AND SUBACUTE NSTEMI COMPLICATED WITH DECOMPENSATED HEART FAILURE. CORONARY ANGIOGRAPHY REVEALED 2 VESSEL CORONARY ARTERY DISEASE WITH OCCLUSION OF THE OM2 BRANCH OF THE LCX. IN ADDITION, SIGNIFICANT STENOSES WERE NOTED IN THE 1ST DIAGONAL BRANCH OF THE LAD AND THE DISTAL SEGMENT OF THE LAD. PCI OF THE OM2 BRANCH OF THE LCX WAS PERFORMED VIA RIGHT RADIAL ACCESS. THE LESION WAS CROSSED WITH A NON-MDT WIRE AND A NON-MDT BALLOON WAS USED TO PRE-DILATE. A RESOLUTE ONYX RX DRUG ELUTING, 2.5/3.8 MM STENT WAS IMPLANTED IN THE OM2 BRANCH OF THE LCX. FOLLOWING IMPLANTATION OF THE STENT, CONTRAST INJECTION REVEALED TROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 1 FLOW SUGGESTING EITHER NO-FLOW PHENOMENON OR A DISSECTION DISTAL TO THE STENT. INTRACORONARY VERAPAMIL WAS ADMINISTERED BUT IT WAS REPORTED THAT FLOW ONLY INCREASED SLIGHTLY FROM TIMI1 TO TIMI2. A SECOND RESOLUTE ONYX RX DRUG ELUTING STENT (2.25/12MM) WAS IMPLANTED OVERLAPPING DISTAL TO THE PREVIOUSLY IMPLANTED RESOLUTE ONYX. NO IMPROVEMENT IN TIMI 2 FLOW WAS OBSERVED, CONGRUENT WITH NO FLOW PHENOMENON. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT. THE PATIENT CONTINUED TO HAVE PAROXYSMAL ATRIAL FIBRILLATION. THE PATIENT REMAINED HOSPITALISED FOR A FURTHER 8 DAYS FOR TREATMENT FOR DECOMPENSATED HEART FAILURE. THE PATIENT ALSO EXPERIENCED AN UPPER GI BLEED. ASPIRIN WAS STOPPED AND THE PATIENT WAS TREATED WITH RIVAROXIBAN (LIFELONG) AND CLOPIDOGREL FOR 6 MONTHS. ECHOCARDIOGRAPHY WAS CARRIED OUT, REVEALING A SMALL CIRCULAR HAEMODYNAMICALLY INSIGNIFICANT PERICARDIAL EFFUSION WHICH WAS INTERPRETED TO HAVE OCCURRED DUE TO POSTINFARCTION PERICARDITIS (PERICARDITIS EPISTENOCARDICA). 6 WEEKS POST INDEX PROCEDURE AND 4 WEEKS POST LAST ECHOCARDIOGRAM THE PATIENT PRESENTED FOR A PCI STAGED PROCEDURE, COMPLAINING OF FEELING UNWELL AND EXPERIENCING SHORTNESS OF BREATH OCCURRING AT REST. ANGIOGRAPHY REVEALED PATENT STENTS IN THE OM2 BRANCH OF THE LCX WITH TIMI 2 FLOW PERSISTING AND NOT HAVING IMPROVED IN 6 WEEKS. LEFT VENTRICULOGRAPHY REVEALED A MASSIVE LV PSEUDOANEURYSM. THE PATIENT UNDERWENT ON-PUMP CARDIAC SURGERY INCLUDING TWO VESSEL CABG, AN ANEURYSMECTOMY AND A POLYTETRAFLUOROETHYLENE PATCH SUTURED OVER THE LV DEFECT. A BIPOLAR MAZE WAS ALSO PERFORMED TO TREAT THE PAROXYSMAL ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87469 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention