BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG 24F RETURN CANNULA

    MDR report key: 3877060 · Received May 29, 2014

    Report

    Report Number
    2916596-2014-00877
    Event Type
    Death
    Date Received
    May 29, 2014
    Date of Event
    January 20, 2011
    Report Date
    May 1, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION REGARDING THIS EVENT WAS DESCRIBED IN A JOURNAL ARTICLE AND SUBMITTED TO THE MANUFACTURER ON MAY 1,2014 DETAILING THE REPORTED SEPARATION OF THE CANNULA FROM THE BARBED CONNECTOR. NO EQUIPMENT WAS RETURNED FOR EVALUATION. A SPECIFIC CAUSE FOR THIS EVENT COULD NOT BE DETERMINED THROUGH THIS EVALUATION. IT WAS COMMUNICATED THAT ON THE 119TH DAY OF SUPPORT, THE PATIENT¿S CANNULA BECAME DISCONNECTED FROM THE BARBED CONNECTOR. THE MANUFACTURER¿S INSTRUCTIONS FOR USE EXPLAINS THE CANNULA HAS NOT BEEN QUALIFIED THROUGH IN VITRO, IN VIVO, OR CLINICAL STUDIES FOR USE LONGER THAN 30 DAYS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION # J CARD SURG 2013; 28: 472-474, AORTIC CANNULA DISRUPTION FOLLOWING LONG-TERM LVAD SUPPORT. THE CANNULA WILL NOT BE RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION INCLUDES A SUMMARY OF A SINGLE CASE REPORT PUBLISHED IN A JOURNAL ARTICLE: A (B)(6) FEMALE WAS ADMITTED WITH ACUTE HEART FAILURE AND ACUTE PULMONARY EDEMA. TEN DAYS PREVIOUSLY, SHE SUSTAINED AN ANTERO-SEPTAL ST - ELEVATION MYOCARDIAL INFARCTION (STEMI). AN ECHOCARDIOGRAM SHOWED SEVERE DILATATIVE CARDIOMYOPATHY (LEFT VENTRICLE EJECTION FRACTION 15 PERCENT), SEVERE FUNCTIONAL MITRAL REGURGITATION, MODERATE SYSTOLIC DYSFUNCTION OF THE RIGHT VENTRICLE, MODERATE TRICUSPID REGURGITATION, AND PULMONARY HYPERTENSION (SYSTOLIC PULMONARY ARTERIAL PRESSURE 45 MMHG). A CORONARY ANGIOGRAM WAS NORMAL. HER CONDITION QUICKLY WORSENED AND SHE DEVELOPED CARDIOGENIC SHOCK REFRACTORY TO INOTROPES AND INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AND SUCCESSFULLY WEANED AFTER 15 DAYS OF SUPPORT WHEN HER LEFT VENTRICULAR (LV) FUNCTION SEEMED TO SIGNIFICANTLY IMPROVE. HOWEVER, TWO WEEKS LATER, SHE AGAIN DETERIORATED AT WHICH TIME THE HOSPITAL TEAM PROCEEDED WITH IMPLANTATION OF A PARACORPOREAL CENTRIFUGAL LVAD WITH THE CENTRIMAG AS A BRIDGE TO HEART TRANSPLANTATION. ON THE 13TH POSTOPERATIVE DAY, ECHOCARDIOGRAPHY SHOWED AN AKINETIC LV AND THROMBOSIS OF THE AORTIC ROOT. A COMPUTED TOMOGRAPHY (CT) SCAN ALSO REVEALED COMPLETE THROMBOTIC OCCLUSION OF THE LEFT MAIN CORONARY ARTERY. AFTER 4 WEEKS THE PATIENT WAS FULLY AMBULATORY WITH ASSISTANCE IN ORDER TO AVOID CANNULA DISLODGEMENT DURING MOVEMENT. SHE RECEIVED WARFARIN WITH INR 2-2.5. ANTICOAGULATION WAS INEFFECTIVE IN RESOLVING THE ROOT THROMBOSIS. THERE WAS COMPLETE RECOVERY OF ORGAN FUNCTION AND FREEDOM FROM INFECTION AND THEREFORE THE PATIENT WAS PLACED ON THE TRANSPLANT LIST. ON THE 119TH DAY OF SUPPORT THE PATIENT WAS FOUND EXSANGUINATED IN HER BED DUE TO THE DETACHMENT OF THE 9.5 MM BARBED CONNECTOR INTEGRATED IN THE AORTIC CANNULA. THE EVENT WAS PROMPTLY DETECTED BECAUSE THE PATIENT WAS IN A SEMI INTENSIVE UNIT AND SHE WAS MONITORED. PLASMA EXPANDER AND BLOOD TRANSFUSIONS AND OTHER RESUSCITATING MANEUVERS WERE INEFFECTIVE IN MAINTAINING CIRCULATORY PRESSURE AND THE PATIENT DIED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316804 CENTRIMAG 24F RETURN CANNULA DSQ: CENTRIMAG CANNULA DSQ THORATEC SWITZERLAND GMBH 201-50056

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death