BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 6178672 · Received December 15, 2016

    Report

    Report Number
    2024168-2016-08913
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    November 23, 2016
    Report Date
    January 3, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC, INSTRUCTIONS FOR USE SPECIFIES THE RATED BURST PRESSURE (RBP) IS 16 ATM AND CLEARLY STATES NOT TO EXCEED THE RBP. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER RX GRAFTMASTER 3.5X19 REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN EXTENSIVE FREE PERFORATION WITH EXTRAVASATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5X16 RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 22 ATMOSPHERES (ATM) THEN A 3.5X19 RX GRAFTMASTER WAS DEPLOYED AT 18 ATM. EACH GRAFTMASTER REPORTEDLY SEALED THE PERFORATION. AFTER DEPLOYMENT OF THE 2ND GRAFTMASTER, THE PATIENT CONTINUED TO DETERIORATE AND THE PATIENT EXPIRED. THE PATIENT REPORTEDLY HAD VERY LABILE BLOOD PRESSURE TO BEGIN WITH. CSI (INTERPRETED TO MEAN CORONARY SINUS INTERVENTION) WAS PERFORMED PRIOR TO STENTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826883 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 6021741

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death STENT: 3.5X19 RX GRAFTMASTER