BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS 2 CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2802775 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06338
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2012-06337, 2134265-2012-06339, 2134265-2012-06326, 2134265-2012-06327. SAME PATIENT AS: 2134265-2012-06362, 2134265-2012-06363, 2134265-2012-06364. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA, RESTENOSIS AND WENCKEBACK BLOCK REQUIRING INTERVENTION IN (B)(6) 2004, THE PHYSICIAN IMPLANTED 3(THREE) UNKNOWN SIZE EXPRESS 2 STENTS TO THE RIGHT CORONARY ARTERY (RCA). IN SEPTEMBER 2012 THE PATIENT PRESENTED DURING A FOLLOW-UP VISIT WITH A TWO (2) MONTH HISTORY OF PROGRESSIVE DYSPNEA ON EXERTION. ELECTROCARDIOGRAM REVEALED NORMAL SINUS RHYTHM. CARDIOLITE STRESS TEST WAS PERFORMED. HOWEVER, THE PATIENT WENT INTO 2ND DEGREE TYPE 1 WENCKEBACK AV BLOCK WITH MINIMAL ACTIVITY. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. THE PRESENCE OF THE KNOWN CORONARY ARTERY DISEASE IN THE RCA WAS BELIEVED TO BE THE CAUSE OF THE AV BLOCK. AT THE TIME OF THE EVENT THE PATIENT WAS TAKING ASPIRIN AND STUDY MEDICATION. PER (B)(4), THE STUDY DRUG WAS DISCONTINUED. THE 80-90% IN-STENT RESTENOSIS OF THE STUDY STENTS DEPLOYED FROM PROXIMAL TO MID RCA AND THE PREVIOUSLY DEPLOYED EXPRESS STENTS IN THE RCA WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY FOLLOWED BY PLACEMENT OF A 3.0X20MM ION STENT IN THE MID LESION. ANOTHER 3.0X16MM ION STENT WAS DEPLOYED PROXIMALLY RIGHT TO THE OSTIUM. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 10%. OF NOTE, THE PATIENT'S AV BLOCK MARKEDLY IMPROVED POST PERCUTANEOUS CORONARY INTERVENTION OF THE RCA. THE EVENTS OF 2ND DEGREE TYPE 1 BLOCK AND CARDIAC ANGINA WERE CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND OPEN LABEL EFFIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS 2 CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK133

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention