BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2080565 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00278
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    December 5, 2007
    Report Date
    March 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: (MYOCARDIAL INFARCTION).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A DRIVER RX BARE METAL STENT AND TWO OTHER BRAND STENTS WERE IMPLANTED, OVERLAPPING, AS TREATMENT OF COMPLICATION/DISSECTION/BAILOUT, AT THE DISTAL RCA. THREE OTHER BRAND STENTS WERE IMPLANTED AT THE MID RCA AS TREATMENT OF THE TARGET LESION. AN ACUTE STEMI IS REPORTED TO HAVE OCCURRED ON THE SAME DAY AS STENT IMPLANT. PT WAS TAKING ASA AND CLOPIDOGREL 24 HRS PRIOR TO EVENT. IT IS REPORTED THAT THE TARGET LESION WAS INVOLVED, BUT EVENT WAS NOT RELATED TO THE STUDY STENT. LOCATION OF INFARCTION WAS INFERIOR. INVESTIGATOR ASSESSED THE EVENT AS A Q-WAVE MI. IT IS REPORTED THAT PT HAD VF ARREST PRIOR TO BALLOON INFLATION AND WAS DEFIBRILLATED THREE TIMES. MAJOR DISSECTION FOLLOWING USE OF GUIDE WIRE WITH ASSOCIATED ST ELEVATION AND CHEST PAIN. AFTER INSERTION OF THE GUIDE CATHETER, A SPIRAL DISSECTION RESULTED. VESSEL TORTUOSITY MADE IT DIFFICULT FOR BALLOONS, WIRES AND STENTS TO BE DEPLOYED IN THE DISTAL VESSEL. APPROX 2 WEEKS FOLLOWING INDEX PROCEDURE, A REVASCULARIZATION OF THE PROXIMAL LAD WAS CARRIED OUT. ONE DRIVER RX BARE METAL STENT WAS IMPLANTED. IT IS REPORTED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY F/U, 6 MONTH F/U AND 1 YEAR FOLLOW UP. AT 1.5 YR F/U AND 2 YR F/U, PT DISPLAYED UNSTABLE ANGINA. AT 2.5 YR F/U AND AT 3 YR F/U, PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT WAS TAKING ASA 24 HOURS PRIOR TO EVENT| PT WAS TAKING CLOPIDOGREL 24 HOURS PRIOR TO EVENT