BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4090697 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05939
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE STENT REMAINS IN THE PATIENT ANATOMY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SIMILAR INCIDENT QUERY IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS NOT PERFORMED AS THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PATIENT EFFECTS OF DEATH AND THROMBOSIS, AS LISTED IN THE GRAFTMASTER INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE TWO GRAFTMASTERS ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT PRESENTED TO THE HOSPITAL WITH ANGINA. ON (B)(6) 2014, TWO VERY LARGE PERFORATIONS OCCURRED DURING DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.8X16MM GRAFTMASTER, 3.5X16MM GRAFTMASTER, 2.8X19MM GRAFTMASTER STENTS WERE SUCCESSFULLY DEPLOYED, FULLY SEALING THE PERFORATION. POST-DILATATION AND INTRAVASCULAR ULTRASOUND (IVUS) WERE PERFORMED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. APPROXIMATELY TWO HOURS POST-PROCEDURE WHILE RECOVERING IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT EXPERIENCED ANGINA, AND ANGIOGRAM REVEALED ALMOST TOTAL OCCLUSION OF THE LAD DUE TO THROMBOSIS IS THE STENTS. CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY WAS PERFORMED THE SAME DAY. ON (B)(6) 2014, WHILE STILL RECOVERING IN THE HOSPITAL, THE PATIENT EXPERIENCED CARDIOGENIC SHOCK. UNSPECIFIED MEDICATIONS WERE ADMINISTERED; HOWEVER, THE PATIENT EXPIRED. NO REPEAT ANGIOGRAM, IVUS, OR AUTOPSY WAS PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570059 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4010241

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death STENT: 2.8X16MM GRAFTMASTER, 2.8X19MM GRAFTMASTER