BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3142772 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03447
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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. GUIDE WIRE: ASAHI GRAND SLAM. GUIDE CATHETER: LAUNCHER 7 FR. SHEATH: PRELUDE 7 FR. STENT: PROMUS ELEMENT 2.5X22. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DEPLOYING A 2.5X32 NON-ABBOTT STENT IN THE POSTERIOR LATERAL CORONARY BRANCH, A PERFORATION OCCURRED AT THE DISTAL STENT EDGE. TO TREAT THE PERFORATION, A 3.0X19 JOSTENT GRAFTMASTER COVERED STENT SYSTEM WAS INTRODUCED VIA FEMORAL ACCESS, BUT WAS UNABLE TO ADVANCE THROUGH THE MODERATELY TORTUOUS, SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY TO TREAT THE PERFORATION. DESPITE COIL EMBOLIZATION, PERICARDIOCENTESIS, AND MEDICAL MANAGEMENT, THE PATIENT EXPIRED DUE TO COIL EMBOLIZATION FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245139 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 739388

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death