BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1962215 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00364
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT IS 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. IT WAS REPORTED THE PATIENT ANATOMY WAS MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 CALCIFIED ANATOMY WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. 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 A CASCADE OF PATIENT EFFECTS SUCH AS HEMORRHAGE AND ADDITIONAL TREATMENT; 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. ALL SDS ARE INSPECTED 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.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: 1.5MM X 15 MM; 2MM X 20 MM; 2.5MM X 20MM; 3MM X 15MM; 3MM X 20 MM; 3.5MM X 15MM VOYAGER. GUIDE WIRE: 0.014 BALANCE MIDDLEWEIGHT UNIVERSAL 190CM, 300CM; 0.014 ASAHI GRANDSLAM; 0.014 DOC. INFLATION: 20/30 HIGH PRESSURE KIT; GUIDE CATH: 6 FR ; MEDTRONIC 3 EBU; 7 FR SCIMED 3 VL; SHEATH: TERUMO 7 FR; STENT: 2.5 MM X 28 MM MINI VISION; 3.0X28 VISION; 3.0X18 VISION; OTHER: HEPARIN; INTEGRILIN. THE 3.0X18 RX VISION (PART# 1007848-18, LOT UNK) AND THE 3.5 MM X 19 MM GRAFTMASTER (PART# 12745-19, LOT# UNK) ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE CUSTOMER REPORTED THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND A PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY WAS PERFORMED. TWO VISION STENTS WERE ADVANCED BUT COULD NOT CROSS THE TARGET LESION AND WERE REMOVED WITHOUT ISSUE. A 3MM X 18 MM VISION WAS ADVANCED OVER THE GRANDSLAM GUIDE WIRE, POSITIONED ACROSS THE TARGET LESION. DURING STENT DEPLOYMENT THE VISION STENT IMPLANT PARTIALLY DISLODGED FROM THE BALLOON THAT WAS INFLATED AT 14 ATMOSPHERES FOR 10 SECONDS. ADDITIONAL DILATATION WITH A 2 MM X 20 MM VOYAGER RESULTED IN FULL APPOSITION OF THE STENT TO THE VESSEL WALL, PARTIALLY IN THE LESION. THREE ADDITIONAL STENTS WERE DEPLOYED AT UNSPECIFIED LOCATIONS FOLLOWED BY BALLOON DILATATION WITHOUT REPORTED ISSUE. THE PROCEDURE LOG NOTED THAT ANTICOAGULANT MEDICATIONS WERE DISCONTINUED AND A PERFORATION/DISSECTION WAS NOTED. A 3 MM X 12 MM GRAFTMASTER WAS ADVANCED BUT THE STENT DISLODGED PARTIALLY FROM THE BALLOON. A 2MM X 20 MM VOYAGER WAS USED TO APPOSE THE STENT TO THE VESSEL WALL. A SECOND 3.5 MM X 19 MM GRAFTMASTER WAS ADVANCED BUT COULD NOT CROSS THE LESION DESPITE SEVERAL ATTEMPTS AND WAS REMOVED FROM THE ANATOMY. THE PERFORATION/DISSECTION WAS ULTIMATELY TREATED BY THE BALLOON DILATATION AND ADDITIONAL STENT PLACEMENTS. THE PATIENT WAS DISCHARGED FOUR DAYS POST STENT PROCEDURE IN GOOD CONDITION. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention