BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX

    MDR report key: 6459654 · Received April 5, 2017

    Report

    Report Number
    9612164-2017-00368
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    September 9, 2016
    Report Date
    March 7, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUTHORS: MASAO IMAI, MDA, ATSUO FUKUDA, MDB, NOBUHIDE MIYAMOTO, MDB, HIDENORI SAKO, MDB, TAKESHI KIMURA, MD, FJCCA, KATSUMI INOUE, MDC JOURNAL NAME: JAPANESE COLLEGE OF CARDIOLOGY YEAR: 2016 ISSUE #: 14 (2016) 161¿163 TITLE OF ARTICLE: ATHOLOGICAL ANALYSIS OF A CASE WITH PERI-STENT CONTRAST STAINING AFTER BMS IMPLANTATION LITERATURE REFERENCE: HTTP://DX.DOI.ORG/10.1016/J.JCCASE.2016. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT BARE-METAL STENT (BMS) IMPLANTATION IN THE RIGHT CORONARY ARTERY (RCA) FOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE BARE METAL STENT USED WAS A DRIVER BMS. FOLLOWING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS TESTED ALLERGIES TO CHROMIUM. IN THE COURSE OF TREATMENT, THIS PATIENT WAS FOUND TO HAVE CHROMIUM ALLERGY WITH POSITIVE PATCH TEST AFTER STENT IMPLANTATION. IN FOLLOW UP ANGIOGRAPHY AT 7, 11, AND 14 MONTHS AFTER THE INDEX STENT IMPLANTATION, RECURRENT REFRACTORY RE-STENOSIS WITH PERI-STENT CONTRAST STAINING (PSS) FORMATION WAS OBSERVED IN THE STENTED LESION. AFTER 2 REPEATED INTERVENTIONS, THIS PATIENT WAS REFERRED TO CORONARY ARTERY BYPASS GRAFTING DUE TO OCCLUSION OF RCA AND PROGRESSION OF PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY LESION AT 15 MONTHS AFTER STENT IMPLANTATION. PATHOLOGIC EXAMINATION OF THE SURGICALLY RESECTED SPECIMEN OF STENTED RCA SEGMENT REVEALED TOTAL OCCLUSION WITH DENSE FIBROUS COLLAGENOUS TISSUE AND SIGNIFICANT INFLAMMATORY CELL INFILTRATION INCLUDING SCATTERED EOSINOPHILS. EXTENSIVE LOSS OF MEDIAL SMOOTH MUSCLE LAYER WAS OBSERVED IN THE VESSEL WALL, WHICH WAS LIKELY TO BE THE CAUSE OF PSS. IT WAS NOTED IN THE ARTICLE THAT IT IS SUSPECTED THAT THE ALLERGIC REACTIONS TO CHROMIUM RELEASED FROM THE STENT MIGHT BE ONE OF THE TRIGGERING MECHANISMS FOR IN-STENT RESTENOSIS AND PSS AFTER BMS IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241872 DRIVER RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention