BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS 2 CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2802735 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06363
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    December 3, 2010
    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

    (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: 2134265-2012-06362, 2134265-2012-06364. SAME PATIENT AS: 2134265-2012-06337, 2134265-2012-06338, 2134265-2012-06339, 2134265-2012-06326, 2134265-2012-06327. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS AND THROMBOSIS. IN (B)(6) 2004, DURING THE INDEX, THE LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH THE PLACEMENT OF THREE (3) UNKNOWN SIZE EXPRESS 2 STENTS. IN (B)(6) 2010, THE PATIENT PRESENTED WITH PROGRESSIVE CHEST TIGHTNESS RADIATING UP TO THE THROAT AND ASSOCIATED WITH NAUSEA. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IB) AND CARDIAC CATHETERIZATION AS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED PREVIOUSLY DEPLOYED EXPRESS 2 STENTS IN RIGHT CORONARY ARTERY; 60-70% PROXIMAL IN-STENT RESTENOSIS AND 98% SUBTOTAL STENOSIS WITH THROMBUS (POSSIBLE STENT THROMBOSIS) WITHIN THE PREVIOUSLY DEPLOYED STENTS IN MID SEGMENT OF RIGHT CORONARY ARTERY WAS NOTED. THE IN-STENT RESTENOSIS AND THROMBUS TARGET LESION WAS EXTENDING FROM THE PROXIMAL RCA TO MID RCA. THE LESION WAS 99% STENOSED, 3.0MM IN DIAMETER AND 60MM LONG. DURING THE PROCEDURE, THE RCA WAS FIRST CROSSED WITH A GUIDE WIRE DISTALLY FOLLOWED BY ATTEMPTS TO PREDILATE THE LESION USING A 2.0X20MM APEX BALLOON; HOWEVER, THE BALLOON COULD NOT CROSS THE LESION. THE TARGET LESION WAS FIRST TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY PREDILATION AND PLACEMENT OF A 2.75X38MM TAXUS LIBERTE STENT CLEAR DOWN TO THE AREA TREATED WITH ROTABLATION, SHORT OF BIFURCATION DISTALLY. ANOTHER 3.0X32MM TAXUS LIBERTE STENT WAS DEPLOYED BACK TO THE OSTIUM, OVERLAPPING THE 2.75X38MM STENT PROXIMALLY. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 25%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    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 67 YR Required Intervention