BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICAST COVERED STENT

    MDR report key: 2211983 · Received August 8, 2011

    Report

    Report Number
    1219977-2011-00005
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. PICTURES PROVIDED AND ARE BEING EVALUATED ALONG WITH ADD'L INFO RECEIVED. FINAL EVAL RESULTS ARE FORTHCOMING.

    Description of Event or Problem · 1

    PT HOSPITALIZED FOR A BILATERAL ILIAC STENT PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, POST RIGHT AND LEFT PLACEMENT OF STENTS AND POST KISSING TECHNIQUE FOR DILATION OF INFRARENAL ARTERY, IT WAS NOTED THAT THE RIGHT BALLOON HAD RUPTURED. UPON RETRIEVAL OF THE BALLOON OVER THE WIRE, IT WAS NOTED THAT THE TIP WAS MISSING. MULTIPLE ATTEMPTS MADE TO RETRIEVE THE BALLOON TIP INCLUDING PLACEMENT OF A LARGER 8 FRENCH SHEATH AND USING EMBOLECTOMY BALLOON UP ALONGSIDE THE TRAPPED BALLOON. NOT SUCCESSFUL. ARTERY CLAMPED DISTAL AND PROXIMAL TO BALLOON AND ARTERIOTOMY WAS PERFORMED. BALLOON TIP REMOVED AND VASCU-GUARD PATCH ANGIOPLASTY PERFORMED TO RIGHT COMMON FEMORAL ARTERY. PT STAYED HOSPITALIZED OVERNIGHT WITH NO EVIDENCE OF COMPLICATIONS. ADD'L PROCEDURES AND EVENT EXPLAINED TO PT BY SURGEON. BALLOON TIP WAS DISCARDED AND IS NOT AVAILABLE. KISSED STENTS AT THE BIFURCATION AND EVERYTHING WORKED PERFECTLY. AFTER DR (B)(6) DEPLOYED THE STENTS HE USED THE BALLOONS TO ANGIOPLASTY SOME DISEASE IN THE AORTA. THE CALCIUM POPPED ONE OF THE BALLOONS. WHEN DR (B)(6) TRIED TO REMOVE THE BALLOON, A PORTION OF THE BALLOON CAUGHT ON THE SHEATH AND THE SHEATH SLICED THE CATHETER AND LEFT A PORTION OF THE CATHETER AND BALLOON IN THE BODY. DR (B)(6) THEN DID A SMALL CUT DOWN AND SUCCESSFULLY REMOVED THE REMAINING PORTION OF THE CATHETER AND BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85406 10749030

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention