BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 2440373 · Received February 1, 2012

    Report

    Report Number
    3001845648-2012-00005
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    December 14, 2011
    Report Date
    January 5, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBERS FOR THIS PRODUCT ARE: K040505, K043481 AND K051124. THE LOT NUMBER OF THE ZIB6-80-14.0-60 DEVICE INVOLVED IN THIS COMPLAINT IS UNKNOWN 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 EVALUATION. THE COMPLAINT DESCRIPTION CONTAINED THE FOLLOWING INFORMATION: "THE PHYSICIAN WAS GOING IN FROM THE ARM TO STENT A NOMINAL VEIN." THE DEVICE INVOLVED IN THIS COMPLAINT IS A ZIB6-80-14.0-60 DEVICE. THIS IS A ZILVER BILIARY STENT AND THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, IFU0042-4 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 INFORMATION PROVIDED AS IT WAS INSERTED INTO THE ARM TO BE PLACED IN A NOMINAL VEIN AND NOT IN THE BILIARY TREE. PRIOR TO DISTRIBUTION, ALL ZIB6-80-14.0-60 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF MANUFACTURING RECORDS CANNOT BE CONDUCTED AS THE DEVICE LOT NUMBER IS UNKNOWN. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THIS IS CONSIDERED AN ISOLATED INCIDENT. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS GOING IN FROM THE ARM TO STENT A NOMINAL VEIN. WHEN THE STENT DEPLOYED, IT JUMPED FURTHER THAN THE PHYSICIAN WANTED IT TO. THE PHYSICIAN WENT IN WITH A WIRE THROUGH AN 11FR SHEATH AND WHEN THE PHYSICIAN PULLED BACK ON THE STENT IT BROKE IN HALF. HALF OF THE STENT FLOATED UP INTO THE HEART, THE PHYSICIAN RETRIEVED THIS PART BUT IT BROKE AGAIN AND THE PART FLOATED INTO THE PULMONARY VEIN. THE PHYSICIAN RETRIEVED THESE PARTS OF THE STENT. WHILE RETRIEVING ANOTHER PIECE OF THE STENT IT BROKE AGAIN AND FLOATED INTO THE HEART AGAIN. THIS WAS RETRIEVED. THE PHYSICIAN THEN UPSIZED TO A 16 FR SHEATH AND CONTINUED TO RETRIEVE THE PIECES. ALL PIECES WERE CONFIRMED TO HAVE BEEN RETRIEVED AND NO HARM TO THE PATIENT. THE PATIENT STATUS WAS CONFIRMED TO BE DOING OKAY. FROM THE INFORMATION PROVIDED BY THE REPORTER, A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    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 25 YR Life Threatening