BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2040172 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02364
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE REMAINS IN THE PATIENT. FAILURE TO SEAL THE PSEUDOANEURYSM (THE REPORTED LEAK) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, STENT GRAFT FOIL DAMAGE, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PSEUDOANEURYSM OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PSEUDOANEURYSM DURING DEPLOYMENT. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT. IT IS POSSIBLE THAT THE STENT WAS NOT POSITIONED CORRECTLY IN THE ANATOMY TO PROPERLY SEAL THE PSEUDOANEURYSM. HOWEVER, AS THIS CANNOT BE CONFIRMED, A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PSEUDOANEURYSM COULD NOT BE DETERMINED. ADDITIONAL TREATMENT WAS USED TO HELP SEAL THE PSEUDOANEURYSM. IT WAS REPORTED THE GRAFTMASTER STENT WAS USED TO TREAT A PSEUDOANEURYSM. IT SHOULD BE NOTED THE GRAFTMASTER INSTRUCTIONS FOR USE STATES: THE JOSTENT GRAFTMASTER IS A BALLOON-EXPANDABLE PRE-MOUNTED CORONARY STENT GRAFT FOR INTRALUMINAL CHRONIC PLACEMENT IN CORONARY ARTERIES OR AORTO-CORONARY BYPASS GRAFTS FOR THE TREATMENT OF ACUTE CORONARY ARTERY PERFORATIONS. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL AND THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.5X16 JOSTENT GRAFTMASTER STENT GRAFT WAS DEPLOYED FOR TREATMENT OF A PSEUDOANEURYSM IN THE RIGHT RENAL ARTERY. A SECOND 3.5X19 JOSTENT GRAFTMASTER STENT GRAFT WAS DEPLOYED INSIDE THE FIRST GRAFTMASTER TO SEAL THE PSEUDOANEURYSM. THE PATIENT EXPERIENCED A MINOR TRANSIENT ISCHEMIC ATTACK (TIA); HOWEVER, THE PATIENT HAS A HISTORY OF LOW BLOOD COUNT, WHICH WAS NOT TREATED DUE TO RELIGIOUS VIEWS. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT SEQUELA. 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 596929

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention