BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8270773 · Received January 23, 2019

    Report

    Report Number
    9612164-2019-00283
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 19, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THERE WAS SLIGHT TORTUOSITY AND CALCIFICATION AT THE TARGET LESION. AFTER POST-DILATION THE PROXIMAL REGION OF STENT WAS FLOATING. INCOMPLETE STENT APPOSITION WAS CONFIRMED AT THE OSTIUM. IT WAS ASSESSED THAT THERE WAS NO RELEVANT PATIENT MEDICAL HISTORY THAT MAY HAVE MADE THE PATIENT MORE PRONE TO A THROMBOLYTIC EVENT. IT WAS ASSESSED THAT THROMBOSIS MIGHT OCCUR DUE TO THE MALAPPOSITION, AND IT WAS STRANGE THAT THROMBOSIS WAS CAUSED BY THIS DEGREE OF APPOSITION. POST PROCEDURE, THE PATIENT RECOVERED SMOOTHLY. 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 AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A BIFURCATION LESION LOCATED IN THE LAD WITH 75% STENOSIS. THE LESION WAS PRE DILATED AND POST DILATED. IT WAS REPORTED THAT AFTER STENT IMPLANTATION AT 15 ATM FOR 10 SECONDS, KISSING BALLOON TECHNIQUE WAS PERFORMED WITH THE LEFT ANTERIOR DESCENDING ARTERY (MAIN) AND 1ST DIAGONAL (D1). AFTER THAT, THERE WAS A SLIGHT GAP BETWEEN PROXIMAL REGION OF STENT AND THE BLOOD VESSEL WALL, SO POST-DILATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON CATHETER. IT WAS INDICATED THAT THERE WAS NO PROBLEM IF THERE WAS A SLIGHT GAP, AND THE PROCEDURE WAS COMPLETED. APPROX 5 HOURS AFTER THE PROCEDURE THE PATIENT COMPLAINED OF CONSIDERABLE STRONG CHEST PAIN, AND THE PATIENT ENTERED THE CATHETER ROOM ON SUSPICION OF ATRIAL TACHYCARDIA (AT). WHEN THE ANGIOGRAPHY WAS PERFORMED WITH THE DIAGNOSIS CATHETER, A TOTAL OCCLUSION FROM STENTED PROXIMAL REGION TO DISTAL REGION WAS SEEN. THE PATIENTS MEDICATION WAS CHANGED TO HYPERION 7F PB 3.5H. A NON-MEDTRONIC GUIDE WIRE WAS CROSSED AND AN ATTEMPT WAS MADE TO ASPIRATE USING A NON-MEDTRONIC ASPIRATION CATHETER, BUT RESISTANCE WAS FELT IN THE STENTED PROXIMAL REGION, AND IT FAILED TO CROSS. BECAUSE THERE WAS A POSSIBILITY OF PICKING UP THE STRUT OF THE PROXIMAL REGION, WIRING WAS PERFORMED AGAIN WITH THE MICRO CATHETER. AFTER THE LESION WAS RECROSSED, THE NON-MEDTRONIC ASPIRATION CATHETER WAS USED AGAIN TO PASS AND ASPIRATE. ALTHOUGH STENT DEFORMATION WAS NOT OBSERVED FROM IVUS, ISA WAS CONFIRMED AT THE OSTIUM. POST-DILATION WAS PERFORMED WITH A NON-MEDTRONIC NC BALLOON (4.0 X 8MM). AFTER WAITING FOR 10 MINUTES AN ANGIOGRAPH WAS PERFORMED HOWEVER THE THROMBUS IMAGE INCREASED AND POBA WAS PERFORMED AGAIN AND WAITED FOR 10 MINUTES. 8000 UNITS OF HEPARIN WAS ADMINISTERED, HOWEVER, AS THE ACTIVATED COAGULATION TIME (ACT) WAS NOT SUFFICIENTLY PROLONGED TO 232 SECONDS, IT WAS SUGGESTED THAT THERE WAS A POSSIBILITY OF THE THROMBUS BEING CAUSED BY HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), 10 MG OF SLONNON WAS ADMINISTERED. IT WAS ALSO SUGGESTED THAT THE SLIGHT GAP MIGHT BE RELATED TO THE AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64884 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009125837

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention