BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 2097742 · Received April 11, 2011

    Report

    Report Number
    3001845648-2011-00019
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    COOK IRELAND LTD.
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE (B)(4) DEVICE INVOLVED IN THIS COMPLAINT IS UNK; THEREFORE, WE CANNOT DETERMINE IF A DEVICE OF THE SAME LOT NUMBER IS IN STOCK. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVAL. THE COMPLAINT DESCRIPTION CONTAINED THE FOLLOWING INFO: "ZILVER STENT MIGRATED TO THE RIGHT ATRIUM, RESULTING IN OPEN HEART SURGERY. PRODUCT WAS USED OFF LABEL. THE TYPE OF PROCEDURE WAS PLACEMENT OF A STENT IN THE LEFT ILIAC VEIN. THE DEVICE INVOLVED IN THIS COMPLAINT IS A (B)(4) DEVICE. THIS IS A ZILVER BILIARY STENT AND THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, (B)(4), CONTAINS THE FOLLOWING TEXT. "INTENDED USE- THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. WARNINGS- THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAVE NOT BEEN ESTABLISHED." THIS EVENT CAN BE DESCRIBED AS OFF LABEL USE BASED ON THE INFO PROVIDED AS IT WAS USED FOR AN ILIAC PROCEDURE AND NOT IN THE BILIARY TREE. PRIOR TO DISTRIBUTION, ALL (B)(4) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF MFG RECORDS CANNOT BE CONDUCTED AS THE DEVICE LOT NUMBER IS UNK. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS BASED ON THE INFO PROVIDED, THIS COMPLAINT APPEARS TO BE DUE TO USE ERROR. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. ADD'L PMA/510(K) #S K043481 AND K051124.

    Description of Event or Problem · 1

    ZILVER STENT MIGRATED TO THE RIGHT ATRIUM, RESULTING IN OPEN HEART SURGERY. PRODUCT WAS USED OFF LABEL. PT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| O