BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7921868 · Received October 1, 2018

    Report

    Report Number
    9612164-2018-02581
    Event Type
    Injury
    Date Received
    October 1, 2018
    Date of Event
    February 18, 2018
    Report Date
    January 23, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: DATE OF CASE REPORT ACCEPTED. CASE REPORT: EXCIMER LASER IN CONTRAST FOR THE TREATMENT OF ACUTE MI CAUSED BY THROMBOSIS OF UNDEREXPANDED STENT. ZAHEED TAI, BOSTICK HEART CENTER, WINTER HAVEN HOSPITAL, WINTER HAVEN, FLORIDA. CLINICAL CASE REPORTS 2018; 6 (8): 1457¿1463. 2018. THE AUTHORS. CLINICAL CASE REPORTS PUBLISHED BY JOHN WILEY & SONS LTD DOI: 10.1002/CCR3.1537. 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

    PCI WAS PERFORMED ON THE LAD WITH OVERLAPPING 3.0 X 38 MM AND 3.5 X 18MM RESOLUTE DES DEVICES. THERE WAS A SUBOPTIMAL STENT EXPANSION IN THE LAD, AND THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET (DAPT) THERAPY. SIX DAYS LATER THE PATIENT PRESENTED WITH ACUTE ST ELEVATION AND STENT THROMBOSIS. THE PATIENT SUFFERED ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK SECONDARY TO STENT THROMBOSIS OF UNDEREXPANDED STENTS. A WIRE WAS PASSED THROUGH AND SEQUENTIAL BALLOON INFLATIONS WERE CARRIED OUT SIZING UP TO A 4.00 MM BALLOON. ANTEGRADE FLOW WAS RESTORED, BUT DESPITE AGGRESSIVE DILATION, THE LESION DID NOT EXPAND. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. THE PATIENT DEVELOPED CARDIOGENIC SHOCK AND CHEST PAIN AND AN IMPELLA CP WAS PLACED TO STABILIZE THE PATIENT. LASER ATHERECTOMY WAS DONE TO TRY AND EXPAND THE STENT. ANGIOGRAPHY REVEALED A PATENT LAD WITH TIMI 1 FLOW AND UNDEREXPANSION OF THE STENTS AT THE OVERLAP. A 0.9 ELCA CATHETER WAS EASILY ADVANCED THROUGH THE LESION. LASER ATHERECTOMY WAS PERFORMED WITH CONTRAST AT 80/80 (FLUENCY AND RATE) FOR 2 MIN AND THEN AN ATTEMPT TO DILATE WITH A SERIES OF 2.5 AND 3.0 NC BALLOONS WAS PERFORMED. DESPITE HIGH PRESSURE INFLATION AT 26 ATM, THE LESION DID NOT YIELD. A 1.4 ELCA CATHETER WAS ADVANCED TO THE LESION; HOWEVER, IT WOULD NOT ADVANCE THROUGH THE LESION. ATHERECTOMY WAS PERFORMED AT 60/40 FOR 1 MIN WITH CONTRAST PUFFS DURING ATHERECTOMY FOLLOWED BY ATTEMPTED DILATION WITH A 3.0 NC BALLOON WITHOUT RESOLUTION OF THE LESION. IT WAS DECIDED TO USE AN ATHEROTOMY BALLOON AT THIS TIME TO INCREASE THE RADIAL FORCE. A 3.0 X 10 MM NON-MDT DEVICE WAS ADVANCED WITH AN INITIAL INFLATION AT 14 ATM WITHOUT RESOLUTION. THE LESION YIELDED AT 24 ATM. POST-DILATION WAS THEN PERFORMED WITH A 3.75 NC BALLOON WITH RESTORATION OF TIMI 3 FLOW. THE PATIENT WAS WEANED OFF THE IMPELLA AND HAD NO ACUTE ISSUES POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765372 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention