BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2963659 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00168
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    May 7, 2009
    Report Date
    May 8, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 10X38X120CM BALLOON CATHETER DEVICE YIELDED CRIMP MARKS ON BOTH THE BALLOON AND THE CATHETER SHAFT. ALL DEVICE FEATURES WERE PRESENT, LOCATED PROPERLY AND MET ALL REQUIRED SPECS. IN ORDER TO TEST PASSAGE THROUGH THE SHEATH, A NEW 9X59X120 AND A NEW 10X38X120 WERE REMOVED FROM STOCK AND PREPPED FOR TRAVEL THROUGH THE INTRODUCERS. ONCE FULL PASSAGE THROUGH THE INTRODUCER WAS OBSERVED, STENT LOCATION WAS VERIFIED TO BE BETWEEN THE RADIOPAQUE MARKER BANDS ON THE CATHETER SHAFT. BOTH THE 9X59 AND 10X38 BALLOON CATHETER TRAVELED THROUGH EACH 7FR COOK SHUTTLE INTRODUCER WITH NO OBSERVED ISSUES. THERE WAS A NOTED DIFFERENCE IN THE FORCE REQUIRED TO TRAVEL THROUGH THE 7FR INTRODUCER WHEN COMPARING THE 9X59X120 BALLOON CATHETER TO THE 10X38X120 BALLOON CATHETER. THIS IS NORMAL AS THE 10X38X120 IS MOUNTED ON A LOWER PROFILE AND REFERRED TO AS "LOW PROFILE PRODUCT" VERSUS THE "STANDARD PROFILE" OF THE 9X59X120. IT SHOULD BE NOTED THAT ALL STENT RETENTION TESTING POST SIMULATED USE FOR THE V12/ICAST PRODUCT LINES IS CONDUCTED THROUGH A 7FR 55CM COOK SHUTTLE INTRODUCER WITH A TUOHY BORST VALVE. AFTER REVIEWING OUR QUALITY RECORDS FOR THIS LOT NO DEFECTS OR ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 1

    THE ICAST COVERED STENT (9MMX59MMX120CM; CODE: 85419) WOULD NOT TRACK THROUGH 2 COOK 7FR SHUTTLE SHEATHS. THE FIRST ATTEMPT WAS TRIED THROUGH BRACHIAL ACCESS IN THE BODY. THE PHYSICIAN WAS ONLY ABLE TO ADVANCE 15CM INTO THE SHEATH. PHYSICIAN ABORTED THE ICAST INSERTION AT THAT POINT AND REMOVED THE ICAST FROM THE SHEATH. SECOND ATTEMPT WAS MADE WITH ANOTHER 7FR COOK SHUTTLE SHEATH (ON THE TABLE) WITH THE SAME OUTCOME (ICAST ONLY ADVANCED "VERY TIGHTLY" ONLY TRACKING 10-15CM INTO THE SHEATH). PHYSICIAN CHOSE TO UPSIZE TO AN 8FR COOK SHUTTLE SHEATH AND DEPLOYED THE ICAST (ORIGINAL 59MM) SUCCESSFULLY TO THE TARGET. PHYSICIAN ATTEMPTED TO TELESCOPE THE ICAST (10MMX38MMX120CM; CODE: 85424; LOT#: 1048342318) INTO THE 9X59X120 BUT IT BECAME DISLODGED IN SHEATH AND WASN'T USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85424; 85419 10483423; 10356420

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention ICAST (9MMX59MMX120CM) COVERED STENT| 8FR COOK SHUTTLE SHEATH| 2 COOK 7FR SHUTTLE SHEATHS| ICAST (10X38X120) COVERED STENT