BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 5157282 · Received October 16, 2015

    Report

    Report Number
    2024168-2015-06146
    Event Type
    Death
    Date Received
    October 16, 2015
    Date of Event
    September 24, 2015
    Report Date
    December 9, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    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. CLARIFICATION: THE PART NUMBER, 1012581-19, ON THE ATTACHED USER FACILITY MEDWATCH IS INCORRECT. THE CORRECT PART NUMBER IS 1012582-19. 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 THE REPORTED DIFFICULT TO REMOVE, SEPARATION AND FOREIGN BODY IN PATIENT APPEAR TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED PATIENT EFFECTS OF OCCLUSION, HYPOTENSION AND DEATH, AS LISTED IN THE GRAFTMASTER RAPID EXCHANGE (RX) CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE(IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH RECEIVED STATES: EVENT DESC: PATIENT IN FOR SECOND CARDIAC CATH WITHIN TWENTY-FOUR HOURS. DURING PROCEDURE THE BALLOONS WOULD GET STUCK IN THE NARROWER PART OF THE STENT. THE DOCTOR NOTED THAT THE BALLOONS WERE NONCOMPLIANT AND HE THEN NOTICED A PERFORATION. ANOTHER BALLOON WAS INFLATED TO STOP THE BLEEDING, BUT THE PATIENT BECAME HYPOTENSIVE AND CPR WAS STARTED. THERE WAS A PROBABLE BALLOON SEGMENT WHICH DISCONNECTED IN THE STENOTIC AREA OF THE STENT ON THE WIRE. THE MANUFACTURER WOULD LIKE THE DEVICE AND HAS ALSO SENT PAPERWORK TO THE UNIT MANAGER FOR COMPLETION AS TO THE DETAILS OF THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A NON-ABBOTT STENT WAS IMPLANTED WHEN A DISTAL PERFORATION OCCURRED. A 4.0 X 19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED TO SEAL THE PERFORATION. WHEN REMOVING THE DELIVERY SYSTEM FROM THE ANATOMY THERE WAS RESISTANCE WITH THE TORTUOUS AND CALCIFIED LESION AND THE BALLOON SEPARATED AND FLOATED INTO THE LEFT MAIN. THERE WAS NO FLOW PAST THE STENTED SEGMENT AND BEFORE AN ATTEMPT TO RETRIEVE THE SEPARATED BALLOON COULD BE PERFORMED, THE PATIENT BECAME HYPOTENSIVE AND CARDIO PULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688400 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4100341

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death