BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3407074 · Received October 11, 2013

    Report

    Report Number
    2024168-2013-06469
    Event Type
    Death
    Date Received
    October 11, 2013
    Date of Event
    April 8, 2010
    Report Date
    September 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT: GUIDE WIRE: BALANCE MIDDLEWEIGHT; GUIDE CATH: 7F XB 4.0 EBU; PIGTAIL CATHETER; STENT: 3.5X15 DRIVER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IT SHOULD BE NOTED THAT DEATH AND HYPOTENSION ARE LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT PROCEDURES. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WHAT APPEARED TO BE NON-Q-MI (MYOCARDIAL INFARCTION). LEFT HEART CATHETERIZATION WAS PERFORMED FROM RIGHT FEMORAL APPROACH. AFTER DEPLOYMENT OF A 3.5 X 15 NON-ABBOTT STENT IN THE HIGH GRADE/HEAVILY TORTUOUS CIRCUMFLEX ARTERY, A PERFORATION WITH SEVERE FLOW IN THE PERICARDIUM, AND NEAR IMMEDIATE TAMPONADE OCCURRED. AN ATTEMPT WAS MADE TO PLACE A JOSTENT GRAFTMASTER STENT IN THE VESSEL. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND THE PATIENT WAS INTUBATED. SEVERAL MORE UNSUCCESSFUL ATTEMPTS WERE MADE TO PLACE THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) IN THE VESSEL. THE PATIENT WAS IN TAMPONADE AND HEMODYNAMICALLY COMPROMISED BLOOD PRESSURE DROPPED SIGNIFICANTLY AFTER PERFORATION OCCURRED. EMERGENCY PERICARDIOCENTESIS WAS PERFORMED. PIGTAIL CATHETER WAS PLACED AT THE PERICARDIUM. PRESSORS WERE GIVEN AND THE PATIENT WAS RESUSCITATED. BLEEDING COULD NOT BE STOPPED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. PATIENT WAS IN CARDIAC ARREST. ULTIMATELY THE PATIENT WAS PRONOUNCED DEAD IN THE OPERATING ROOM FROM DIFFUSE HEMORRHAGE FROM MULTIPLE TISSUES AND SURFACES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522498 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death