BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 6181388 · Received December 16, 2016

    Report

    Report Number
    2024168-2016-08956
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 16, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176364
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF DEATH AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE, IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.8 X 26 MM GRAFTMASTER STENT DELIVERY SYSTEM FAILED TO CROSS FOR TREATMENT OF THE LONG PERFORATION THAT OCCURRED DURING USE OF ANOTHER DEVICE. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL TERTIARY CENTER WHERE IT WAS DETERMINED THAT SHE WAS NOT A CANDIDATE FOR SURGERY DUE TO A PREVIOUSLY PERFORMED CORONARY BYPASS PROCEDURE. ALTHOUGH THE PATIENT WAS SENT TO THE CATH LAB, AFTER ARRIVAL, IT WAS DETERMINED THAT NO TREATMENT COULD BE PERFORMED. THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832841 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 6050941 08717648176364

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death