BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 3150631 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-04036
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: 1992 (B)(6). JOURNAL ARTICLE CITATION: EFFICACY OF VENOUS SAC EMBOLIZATION FOR PULMONARY ARTERIOVENOUS MALFORMATIONS: COMPARISON WITH FEEDING ARTERY EMBOLIZATION. SADAO HAYASHI, MD, PHD. DEPARTMENT OF RADIOLOGY, KAGOSHIMA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES, 8-35-1 SAKURAGAOKA, KAGOSHIMA-SHI, KAGOSHIMA 890-8520, JAPAN. 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

    SAME PATIENT AS MDR ID: 2134265-2013-04040. IT WAS REPORTED VIA JOURNAL ARTICLE THAT POST AN EMBOLIZATION TREATMENT PROCEDURE, REPERFUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A FEEDING ARTERY EMBOLIZATION (FAE) FOR TREATMENT OF A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM). WHEN THE FEEDING ARTERY OF THE PAVM WAS VISUALIZED, A JB1 CATHETER WAS INSERTED INTO THE FEEDING ARTERY AND ADVANCED AS CLOSE TO THE VENOUS SAC AS POSSIBLE. FAE WAS PERFORMED USING 0.035-INCH VORTX 35 PLATINUM COILS, IN ADDITION TO 0.035-INCH NON-BSC COILS. THE DIAMETER OF THE COILS USED WAS ABOUT 20% LARGER THAN THE DIAMETER OF THE FEEDING ARTERY UNDERGOING EMBOLIZATION. COMPLETE OCCLUSION OF THE FEEDING ARTERY WAS CONFIRMED WITH PULMONARY ANGIOGRAPHY PERFORMED AFTER EMBOLIZATION. AT THE 23 AND 24 MONTH FOLLOW UP, REPERFUSION OF THE PAVM WAS CONFIRMED WITH PULMONARY ARTERIOGRAPHY AND BRONCHIAL ARTERIOGRAPHY. THE PATIENTS' REPERFUSED ARTERY WAS NOTED TO BE RECANALIZED. TO MANAGE THE REPERFUSIONS, THE PATIENT UNDERWENT AN ADDITIONAL FAE. REPERFUSION WAS DEFINED AS "SAC OR DRAINING VEIN BLOOD FLOW REGARDLESS OF THE INFLOW ROUTE AND RECANALIZATION AS SAC BLOOD FLOW FROM THE RECANALIZED ARTERY THAT HAD PREVIOUS EMBOLIZATION WITH COILS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251750 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention