BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3944858 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04633
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR A STENT GRAFT LEAK REPORTED FROM THIS LOT. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE CORONARY STENT GRAFT SYSTEM, GRAFTMASTER RX INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH CORONARY STENTING. 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. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE LIMA GRAFT TO THE LEFT ANTERIOR DESCENDING (LAD) WITH THE USE OF A NON-ABBOTT DEVICE, HOWEVER, IT WAS NOTED THAT THE 2.80 X 19 MM GRAFTMASTER WAS DEPLOYED TO COVER THE AREA OF THE PERFORATION BUT DID NOT COMPLETELY SEAL WHERE THE PERFORATION WAS SUSPECTED. TWO 2.80 X 16 MM GRAFTMASTER STENTS WERE DEPLOYED AT 14 ATMOSPHERE (ATM) TO COVER AND TREAT THE PERFORATION WITHOUT REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT 3 DAYS POST PROCEDURE THE PATIENT DIED. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422219 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3110741

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death GRAFTMASTER 2.8X16 MM (X2)