BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 9133586 · Received September 30, 2019

    Report

    Report Number
    9612164-2019-04135
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    March 26, 2019
    Report Date
    September 30, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: RECURRENT CORONARY THROMBUS IN PATIENT WITH CHRONIC IMMUNE THROMBOCYTOPENIA WITH TREATMENT USING ELTROMBOPAG. DATE OF PUBLICATION DOI.ORG/10.1155/2019/2756319. IMAGE REVIEW: CAG ( CORONARY ANGIOGRAPHY) ELECTROCARDIOGRAPHY (ECG) AND CARDIAC MAGNETIC RESONANCE IMAGING (C-MRI) WERE PROVIDED OF THE FIRST ADMISSION OF THE PATIENT SHOWING NO SIGNIFICANT CHANGE EXCEPT A LEFT AXIS DEVIATION, NO CORONARY ARTERY OCCLUSION EITHER IN THE RCA OR LCA AND DELAYED ENHANCEMENT OF THE MYOCARDIUM. CAG AND INTRAVASCULAR ULTRASOUND IMAGES PROVIDED AFTER IMPLANTATION OF THE RESOLUTE INTEGRITY STENT DURING THE FIRST PCI SHOW A MASSIVE THROMBUS IN THE STENT LESION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL THAT A CASE STUDY PATIENT WAS ADMITTED TO HOSPITAL WITH SEVERE CHEST PAIN. CARDIAC CATHETERIZATION WAS PERFORMED URGENTLY DUE TO INCREASE OF SERUM MYOCARDIAL ENZYMES. CAG REVEALED NO ARTERY OCCLUSION, LEFT VENTRICULOGRAPHY SHOWED MILD HYPOKINESE IN THE POSTERIOR WALL AND CARDIAC MAGNETIC RESONANCE IMAGING SUGGESTED MI OF THE TERRITORY OF THE LCX. PATIENT WAS DISCHARGED BUT COMPLAINED OF CHEST PAIN POST DISCHARGE. 3 MONTHS LATER THE PATIENT RETURNED AND CAG REVEALED NEW STENOSIS IN THE OM BRANCHES AND ADENOSINE STRESS MYOCARDIAL ISCHEMIA OF THE POSTERIOR WALL. A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED IN THE OM BRANCH SUCCESSFULLY WITH NO RESIDUAL STENOSIS. 3 HOURS AFTER PCI, PATIENT EXPERIENCED SEVERE CHEST PAIN WITH SIGNIFICANT ST DEPRESSION. CAG WAS CARRIED OUT AND STENT THROMBOSIS WAS NOTED AT THE PROXIMAL EDGE OF THE STENT. A NON-MEDTRONIC STENT WAS IMPLANTED AT THE PROXIMAL EDGE OF THE RESOLUTE INTEGRITY. ANTIPLATELET WAS CHANGED FROM CLOPIDOGREL TO PRASUGREL TO AVOID FURTHER STENT THROMBOSIS. 3 DAYS LATER FURTHER CAG REVEALED A MASSIVE THROMBUS WITH 75% STENOSIS IN THE OM BRANCH VESSEL. UROKINASE WAS INJECTED INTO THE LC X INSTEAD OF BALLOON PCI . FURTHER CAG SHOWED A REDUCTION OF STENOSIS TO 50%. 14 DAYS LATER CAG REVEALED THE RECURRENCE OF THROMBUS AND 75% STENOSIS. CORONARY THROMBOSIS ASPIRATION WAS PERFORMED AS 4TH PCI. THE PATIENT ALSO UNDERWENT A SPLENECTOMY TO TACKLE ELTROMBOPAG WHICH WAS SUSPECTED AS HAVING AN ASSOCIATION WITH THE RECURRENCE OF THROMBOSIS. AFTER THE PROCEDURE, THE PATIENT HAS HAD NO COMPLAINTS OF CHEST PAIN AND FOLLOW UP CAG SHOWED NO THROMBUS IN THE TREATED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928469 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention