BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BLUE .018 TRANSPHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1298176 · Received January 27, 2009

    Report

    Report Number
    9610978-2009-00024
    Event Type
    Injury
    Date Received
    January 27, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K040413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SPECULATED THAT AT THE TIME THE PALMAZ BLUE STENT WAS IMPLANTED, THE STENT WAS LEFT IMPLANTED SLIGHTLY PROTRUDING INTO THE AORTA. THEREAFTER DURING THE FOLLOW UP ANGIOGRAM WHEN THE DIAGNOSTIC CATHETER WAS ADVANCED THROUGH THE AORTA, IT CAUGHT PART OF THE STENT FRACTURING ONE CELL. SUBSEQUENTLY, THE FRACTURED PIECE MIGRATED TO THE LEFT ILIAC ARTERY WHERE IT WAS SECURED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND BOTH THE CELIAC ARTERY AND LEFT ILIAC ARTERY ARE PATENT. IT IS UNKNOWN WHICH ONE OF THE TWO IMPLANTED PALMAZ BLUE STENTS WAS FRACTURED. A REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THIS PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER 9610978-2009-00025.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED A PALMAZ BLUE STENT FRACTURED, SEPARATED AND MIGRATED. AS INDICATED APPROXIMATELY 3 TO 4 MONTHS AGO TWO PALMAZ BLUE STENTS WERE IMPLANTED IN THE PATIENT'S CELIAC ARTERY. THEREAFTER AN ULTRASOUND TEST WAS PERFORMED SHOWING INCREASE VESSEL VELOCITY THEREFORE SUSPECTING OF LESION RESTENOSIS. CONSEQUENTLY, A DIAGNOSTIC CATHERIZATION WAS PERFORMED TO RULE OUT RESTENOSIS. A DIAGNOSTIC CATHETER (UNK MFR.) WAS PLACED IN THE AORTA AND THE ARTERIOGRAM WAS PERFORMED VISUALIZING A SEPARATED PIECE OF THE PALMAZ BLUE STENT (PREVIOUSLY IMPLANTED IN THE CELIAC ARTERY) ABOUT 2 TO 3 CM FROM THE OS OF THE CELIAC ARTERY MIGRATING THROUGH THE ABDOMINAL AORTA CAUDALLY. THE SEPARATED PIECE ULTIMATELY MIGRATED TO THE LEFT ILIAC ARTERY WHERE AN EXPRESS STENT (BOSTON SCIENTIFIC) WAS DEPLOYED. THE MIGRATED STENT PIECE WAS TACKED DOWN TO THE VESSEL. IN ADDITION, THE ARTERIOGRAM SHOWED THE CELIAC ARTERY PATENT WITH NO EVIDENCE OF RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BLUE .018 TRANSPHEPATIC BILIARY STENT SYSTEM ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0408436

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention