BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3900412 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04174
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.8X19 MM GRAFTMASTER STENT IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    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 FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR LEAK REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE CORONARY STENT GRAFT SYSTEM, GRAFTMASTER RX INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS BEING USED TO TREAT A PERFORATION CAUSED BY ANOTHER DEVICE IN THE RIGHT CORONARY ARTERY. A 3.5X16 MM GRAFTMASTER STENT WAS DEPLOYED FOR TREATMENT; HOWEVER, DID NOT SEAL THE PERFORATION. THE DECISION WAS MADE TO PLACE TWO ADDITIONAL GRAFTMASTER STENTS, A 3.5X16 MM AND A 3.5X19 MM TO ENSURE COMPLETE SEALING OF THE PERFORATION SUCCESSFULLY. ALSO SOMETIME DURING THE PROCEDURE A 2.8X19 MM GRAFTMASTER STENT WAS ALSO ATTEMPTED TO CROSS; HOWEVER,DID NOT CROSS. THE PROXIMAL SHAFT OF THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) SEPARATED DURING THE ATTEMPT TO CROSS AND WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE PROCEDURE ENDED AND THE PATIENT WAS FINE POST-PROCEDURE; HOWEVER, APPROXIMATELY 6 HOURS LATER THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377021 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4030341

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death STENT: 3.5 X 16 MM & 3.5 X19 MM GRAFTMASTER