BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS 2 CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1990817 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00191
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KYOUNGHOON LEE, WOONG CHOL KANG; LONG-TERM OUTCOME OF DRUG-ELUTING STENT FOR CORONARY ARTERY STENOSIS IN TAKAYASU'S ARTERITIS. DEPARTMENT OF CARDIOLOGY, GIL MEDICAL CENTER. DEVICE IS A COMBINATION PRODUCT. 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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION TO REPORT, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND HYPERTENSION. ANGIOGRAPHY REVEALED TOTAL OCCLUSION IN BOTH SUBCLAVIAN ARTERIES. THE TARGET LESION WITH TIGHT OSTIAL STENOSIS WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA). AN ADDITIONAL TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X12MM TAXUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LMCA AND THE STENT WAS DEPLOYED. NEXT, A 4.5X16MM EXPRESS SDS WAS ADVANCED TO THE RCA AND THE STENT WAS SUCCESSFULLY DEPLOYED. FINAL ANGIOGRAPHIC RESULTS WERE GOOD. SIX MONTHS LATER, A FOLLOW-UP ANGIOGRAPHY REVEALED THAT THE TAXUS STENT WAS PATENT WITH MINIMAL NEOINTIMAL HYPERPLASIA. HOWEVER, THE 4.5X16MM EXPRESS STENT HAD TIGHT IN-STENT RESTENOSIS WITH SEVERE NEOINTIMAL HYPERPLASIA PROLIFERATION. A 3.5X23MM NON-BSC STENT WAS USED TO TREAT THE RESTENOSED EXPRESS STENT. ANGIOGRAPHY SHOWED GOOD RESULTS. EIGHT MONTHS LATER, ANGIOGRAPHY REVEALED NO SIGNIFICANT CHANGE WITH THE LMCA OR RCA. FOUR YEARS LATER, ANGIOGRAPHY REVEALED SEVERE RESTENOSIS AT BOTH THE LMCA AND RCA, WHICH WAS TREATED WITH BYPASS SURGERY.

    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 H7493504016450

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention