BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3234065 · Received July 18, 2013

    Report

    Report Number
    2024168-2013-04510
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2011
    Report Date
    June 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL GRAFTMASTER DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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 DURING THE HIGH RISK PERCUTANEOUS CORONARY INTERVENTION IN THE RIGHT CORONARY ARTERY (RCA) VIA RADIAL ACCESS, A PERFORATION OCCURRED. BALLOON INFLATIONS WERE PERFORMED USING A 4.0 X 20 NON-ABBOTT BALLOON IN AN ATTEMPT TO ENLARGE THE RCA FOR ADVANCEMENT OF A 3.0X26 OTW GRAFT MASTER STENT DELIVERY SYSTEM. ADVANCEMENT OF THE STENT DELIVERY SYSTEM WAS NOT SUCCESSFUL AND THE DEVICE WAS WITHDRAWN FROM THE ANATOMY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE A 3.0 X 19 OTW GRAFT MASTER STENT DELIVERY SYSTEM. A S'PORT GUIDE WIRE WAS ADVANCED TO USE AS A BUDDY WIRE BUT ALSO COULD NOT CROSS. AT THIS TIME, 20 MG OF PROTAMINE WAS GIVEN TO THE PATIENT TO REVERSE THE HEPARIN. ANGIOGRAMS DEMONSTRATED THE PERFORATION WAS MUCH LESS SEVERE ALTHOUGH THE PATIENT BECAME HYPOTENSIVE REQUIRING IV FLUID AND PRESSORS. AN ECHOCARDIOGRAM WAS PERFORMED AND DEMONSTRATED A PERICARDIAL EFFUSION. A PERICARDIAL NEEDLE WAS PLACED IN THE PERICARDIAL SPACE AND THE PERICARDIUM DRAIN PASSED WITH REMOVAL OF 200ML OF BLOOD. AFTER REMOVAL OF THIS BLOODY PERICARDIAL EFFUSION THE PATIENT'S PRESSURE RESPONDED DRAMATICALLY AND HE WAS ABLE TO GET DOWN TO A MINIMAL DOSE OF PRESSORS. THE PATIENT WAS INTUBATED DURING THIS PROCEDURE. FOLLOW-UP ANGIOGRAMS DEMONSTRATED A WIDELY PATENT RIGHT CORONARY ARTERY STENT. THE PERICARDIAL DRAIN WAS SUTURED IN PLACE AND THE PATIENT WAS TRANSPORTED TO THE CCU INTUBATED BUT IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333638 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R