BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 6145850 · Received December 5, 2016

    Report

    Report Number
    2024168-2016-08584
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 5, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176340
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST AND DEATH AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE, ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. 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 TWO ADDITIONAL DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH 99% OCCLUSION. THE INDEX PROCEDURE DATE WAS (B)(6) 2016. A PERFORATION OCCURRED DURING THE PROCEDURE AND THREE 2.8X16MM GRAFTMASTER STENTS WERE IMPLANTED. AT LEAST ONE OF THE GRAFTMASTER STENTS FAILED TO SEAL THE PERFORATION CORRECTLY. THUS, COILS WERE ALSO USED IN THE ARTERY TO PREVENT FURTHER BLEEDING. PERICARDIOCENTESIS WAS PERFORMED. WHILE IN THE CRITICAL CARE UNIT, THE PATIENT BECAME SYMPTOMATIC WITH CARDIAC ARREST AND CARDIO PULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT EXPIRED (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795565 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 5120141 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death STENT: 2.8X16 GRAFTMMASTER (2)