BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3140883 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03435
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: STABPLUS; CORDIS CAR STABILIZER PLUS. SHEATH: 6F RAABE 55CM.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. IT SHOULD BE NOTED THAT THE JOSTENT GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES: IF MORE THAN ONE STENT GRAFT IS REQUIRED, THE DISTAL STENT GRAFT SHOULD BE PLACED INITIALLY, FOLLOWED BY PLACEMENT OF THE PROXIMAL STENT GRAFT. STENT GRAFT PLACEMENT IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT GRAFT WHEN PLACING THE DISTAL STENT GRAFT, AND REDUCES THE CHANCES FOR DISLODGING THE PROXIMAL STENT GRAFT. BECAUSE IT WAS REPORTED THAT THE OTW GRAFTMASTER WAS USED TO TREAT AN EXISTING 1-CENTIMETER SACCULAR ANEURYSM OF THE GASTRODUODENAL ARTERY, IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER IFU STATES: THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. IT WAS ALSO REPORTED THAT THE PHYSICIAN COMMENTED THAT THE RIGIDITY OF THE STENT MAKES OVERLAPPING OR ADVANCING DISTAL TO PREVIOUS STENTS DIFFICULT. AS PREVIOUSLY STATED, THE IFU STATES THAT IF MORE THAN ONE STENT GRAFT IS REQUIRED, THE DISTAL STENT GRAFT SHOULD BE PLACED INITIALLY, FOLLOWED BY PLACEMENT OF THE PROXIMAL STENT GRAFT. THE STENT GRAFT IS DESIGNED TO TREAT PERFORATIONS AND THE RIGIDITY OF THE STENT IS REQUIRED. IT IS LIKELY THAT THE DIFFICULTY CROSSING THE FIRST STENT MADE THE STENT APPEAR TO FEEL TOO RIGID. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DISTAL TO STENT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES: THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. THE STENT GRAFT IS DESIGNED TO TREAT PERFORATIONS AND THE RIGIDITY OF THE STENT IS REQUIRED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ADDITIONAL 4.0 X 12 MM AND 3.5 X 12 MM JOSTENT GRAFTMASTER STENTS MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER NUMBERS. (B)(4) - INCORRECT ANATOMY; INDICATION FOR USE; DISTAL TO STENT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244820 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention STENT: 4.0 X 12 AND 3.5X12 JOSTENT GRAFTMASTER