BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMULA 418 BILIARY BALLOON EXPANDABLE STENT

    MDR report key: 1894554 · Received November 5, 2010

    Report

    Report Number
    1820334-2010-00549
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K051785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT CODE - NO ADVERSE CONDITION WAS REPORTED. DEVICE CODE - SEPARATES IS NOT SPECIFICALLY ADDRESSED IN THE IFU. NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION. DESIGN VERIFICATION AND VALIDATION ACTIVITIES PERFORMED DURING DEVELOPMENT. DEPLOYMENT TESTING, INCLUDING EVAL OF STENT STRIPPING DURING DELIVERY, WAS PERFORMED. PER QUALITY CONTROL SPECIFICATION, THE DEVICE IS 100% INSPECTED, VERIFYING THAT THE STENT IS POSITIONED CORRECTLY ON THE BALLOON AND THAT THERE IS A SMOOTH TRANSITION BETWEEN THE ENDS OF THE STENT AND THE BALLOON TAPER. ADD'L MEASURES HAVE BEEN TAKEN, INCREASING THE CRIMPING PRESSURE AND HEAT SET TIME. THESE CHANGES INCREASED STENT SECUREMENT BY 20%. ADD'L CONTROLS WERE ADDED DURING PROCESSING, THUS REDUCING VARIATION IN STENT SECUREMENT STRENGTH. THIS DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION. THE DEVICE IS SHIPPED WITH IFU THAT STATES, "THE (B)(4) STENT IS INTENDED FOR USE.. IN THE BILIARY TREE." TORTUOUS ANATOMY AND OFF-LABEL USE MAY INCREASE THE POSSIBILITY OF THE STENT COMING OFF THE BALLOON. LIMITED INFO WAS PROVIDED. POSSIBLE CONTRIBUTING FACTORS WERE NOT REPORTED AND IT IS UNK AT THIS TIME WHEN THE STENT BECAME DISLODGED FROM THE BALLOON. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUED TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED AND NO ADD'L ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    TWO COOK (B)(4) STENTS (SIZE 7X12X80CM) AND SIZE 7X20X80CM (1820334-2010-00548) WERE BEING DEPLOYED INDIVIDUALLY IN EACH OF THE VESSELS, CELIAC AND SUPERIOR MESENTERIC ARTERIES. BOTH STENTS WERE REPORTED AS "COMING OFF THE BALLOON". AFTER BOTH STENTS WERE SNARED, THE PHYSICIAN ASKED FOR TWO ADD'L STENTS, ONE EACH FROM DIFFERENT MDR'S; ONE 7X24 AND ONE, 8X18MM. THE STENTS WERE SUCCESSFULLY DELIVERED AND THE PT TOLERATED THE PROCEDURE W/O FURTHER COMPLICATIONS. THE HOSPITAL'S STAFF DISPOSED OF THE STENT CATHETERS. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA 418 BILIARY BALLOON EXPANDABLE STENT FGE, CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC NA 2349913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention