BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3150544 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03528
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE 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. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION FROM THE JOURNAL OF INVASIVE CARDIOLOGY 2013; 25:E93-E95): "A CORONARY PSEUDOANEURYSM WITHIN A RESTENOTIC STENT TREATED BY IMPLANTATION OF A PERICARDIUM-COVERED STENT AND DRUG-ELUTING BALLOON." IT WAS REPORTED THAT AN UNSPECIFIED JOSTENT GRAFTMASTER COVERED STENT HAD LOW TRACKABILITY DUE TO THE BULKY PROFILE PRODUCED BY ITS SANDWICH-LIKE STRUCTURE AND DUE TO VESSEL TORTUOSITY, WHICH RESULTED IN A FAILURE TO CROSS AND FAILURE TO TREAT AN EXISTING PERFORATION IN THE DISTAL CIRCUMFLEX CORONARY ARTERY. A PERICARDIOCENTESIS WAS PERFORMED, FOLLOWED BY PROLONGED BALLOON INFLATIONS, AND PROTAMINE DRUG ADMINISTRATION, ULTIMATELY SEALING THE PERFORATION. THERE WAS NO FATALITY. THE PATIENT WAS DISCHARGED IN GOOD CONDITION, WITHOUT BLEEDING RELATED COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250457 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention