BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2002980 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01241
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT WAS RETURNED; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED. BLOOD WAS VISIBLE ON THE WHITE FOIL, CONSISTENT WITH HANDLING. THERE WAS NO DAMAGE NOTED TO THE STENT AND FOIL. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WITH THE CASE INFORMATION WHICH MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE AN INTERACTION WITH THE LESION/ANATOMY DURING ADVANCEMENT IN THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. SUBSEQUENT INTERACTION WITH THE ANATOMY WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED DURING THE MANUFACTURING PROCESS FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. DUE TO THE INHERENTLY SERIOUS AND EMERGENT USE OF THE GRAFTMASTER DEVICE, THE PERFORATION ITSELF AND/OR THE FAILURE TO TREAT THE PERFORATION MAY HAVE POSSIBLY RESULTED IN CASCADE OF PATIENT EFFECTS AND ADDITIONAL TREATMENTS; HOWEVER, THEIR RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE XIENCE V STENT, IS BEING REPORTED UNDER A SEPARATE MEDWATCH MFR REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE A XIENCE V STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. POST STENT DEPLOYMENT A PERFORATION WAS SEEN IN THE LAD. A GRAFTMASTER STENT DELIVERY SYSTEM WAS ADVANCED, INTENDED TO TREAT THE PERFORATION, HOWEVER, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS RETRIEVED USING ANOTHER BALLOON AND WAS REMOVED FROM THE BODY. THE PATIENT DEVELOPED CARDIAC TAMPONADE AND UNDERWENT SINGLE VESSEL CORONARY ARTERY BYPASS. POST-OPERATIVELY THE PATIENT WAS STABLE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 601024

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R| S XIENCE V OTW 2.5X28 STENT