BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4123238 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06252
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. THE PATIENT EFFECT OF DEATH, AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH THE USE OF THE GRAFTMASTER RX CORONARY STENT GRAFT IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THREE NON-ABBOTT STENTS WERE IMPLANTED IN THE RIGHT CORONARY ARTERY. ON (B)(6) 2014 THE PATIENT WAS TAKEN TO THE CATH LAB FOR FOLLOW-UP AND DURING THE PROCEDURE A PERFORATION OCCURRED WITH A NON-ABBOTT DEVICE. A 3.5 X 19 MM RX GRAFTMASTER COULD NOT CROSS THE LESION. A 3.0 X 19 OTW GRAFTMASTER WAS OPENED; HOWEVER, BEFORE IT WAS USED, IT WAS DECIDED THAT THE PATIENT NEEDED SURGERY. THREE DAYS LATER THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602471 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4043041

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death