BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2993135 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01321
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2007
    Report Date
    February 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DATE OF EVENT ESTIMATED AS (B)(6) 2007. IMPLANT DATE ESTIMATED AS (B)(6) 2007. 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 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 PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THAT 6-8 YEARS AGO, WHILE WORKING AT A DIFFERENT HOSPITAL, HE WANTED TO PLACE A GRAFTMASTER STENT IN THE LEFT ANTERIOR DESCENDING ARTERY DURING AN EMERGENCY CASE. HE COULD NOT RECALL IF THIS WAS A PERFORATION. THERE STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM), BUT THE GRAFTMASTER STENT STUCK TO THE BALLOON AND IT WAS NOT POSSIBLE TO REMOVE THE DEVICE. THE SDS WAS RETRIEVED BACK INTO THE LEFT MAIN BRANCH WITH THE STENT STILL ON THE BALLOON. THE PHYSICIAN COULD NOT REMEMBER ANY DETAILS AFTER THAT AND IT IS UNCLEAR IF HE MANAGED TO REMOVE THE SDS WITH THE STENT STILL ON IT OR IF THE STENT WAS PLACED IN THE LEFT MAIN BRANCH AND REMAINED THERE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97478 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention