BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 5012314 · Received August 18, 2015

    Report

    Report Number
    2024168-2015-04732
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 18, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (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. IT HAS BEEN DETERMINED THAT A CONCLUSIVE CAUSE FOR THE REPORTED STENT GRAFT LEAK AND PATIENT EFFECTS CANNOT BE DETERMINED. 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 IDENTIFIED NO OTHER INCIDENTS. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE GRAFTMASTER RAPID EXCHANGE (RX) CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION. ATHERECTOMY WAS PERFORMED; HOWEVER, A PERFORATION OCCURRED. DILATATION WAS PERFORMED AND A BARE METAL STENT WAS IMPLANTED, BUT THE PERFORATION CONTINUED TO LEAK. THE 4.0 X 19 MM GRAFTMASTER STENT WAS IMPLANTED FOR TREATMENT, BUT THE PERFORATION WAS NOT SEALED; THEREFORE, THE PATIENT WAS SENT TO THE OPERATING ROOM. THERE WAS A DELAY IN GETTING THE PATIENT TO SURGERY, BUT THE PATIENT WENT INTO CARDIAC ARREST. DESPITE PROLONGED RESUSCITATION ATTEMPTS, THE PATIENT DIED. THE CAUSE OF DEATH WAS DUE TO THE UNTREATED PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544466 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4120842

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death