BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG RVAS

    MDR report key: 7085874 · Received December 6, 2017

    Report

    Report Number
    2916596-2017-03066
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    August 30, 2016
    Report Date
    April 6, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    OJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CENTRIMAG CIRCUIT WAS DISCARDED; THEREFORE, A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. INFORMATION WAS COMMUNICATED VIA A JOURNAL ARTICLE THAT ON POST-OP DAY 4, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A THROMBOTIC MASS EXTRACTION FROM THE RIGHT VENTRICLE. ACCORDING TO INFORMATION THAT WAS LATER PROVIDED, THE CAUSE FOR THE MASS WAS UNKNOWN AND THE CENTRIMAG PUMP FUNCTIONED AS EXPECTED. THE CIRCUIT WAS INTENTIONALLY EXCHANGED AT THE TIME OF THE MASS EXTRACTION DUE TO A CHANGE IN CANNULATION SITES AND WAS SUBSEQUENTLY DISCARDED. THE INSTRUCTIONS FOR USE EXPLAINS THAT THROMBOEMBOLIC PHENOMENA ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH THE USE OF THE CENTRIMAG SYSTEM. THIS DOCUMENT ALSO CAUTIONS THE USER TO ALWAYS HAVE A SPARE CENTRIMAG BLOOD PUMP, BACK-UP CONSOLE, AND EQUIPMENT READILY AVAILABLE FOR CHANGE OUT. THE SERIAL NUMBER OF THE DEVICE WAS NOT REPORTED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE EXPIRATION DATE, MANUFACTURE DATE AND DEVICE UNIQUE IDENTIFIER (UDI) ARE UNKNOWN. APPROXIMATE AGE OF DEVICE ¿ 4 DAYS. THE INFORMATION REGARDING THE PATIENT''S OUTCOME ASSOCIATED WITH THE DURABLE LVAD DEVICE OCCURRED WHEN THE LVAD WAS UNDER INVESTIGATIONAL DEVICE EXEMPTION. THIS EVENT CAPTURES THE THROMBUS EXTRACTION ON THE RIGHT VENTRICULAR ASSIST DEVICE. THE EVENT OCCURRED AT (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REGARDING THE STROKE WAS RECEIVED WHICH INDICATED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017 DUE TO LEFT SIDE HEMIPLEGIA. THE SYMPTOMS REPORTEDLY STARTED THE DAY BEFORE (ON (B)(6) 2017) BUT THE PATIENT DID NOT IMMEDIATELY PRESENT TO THE HOSPITAL. AT THE TIME OF THE EVENT, THE PATIENT WAS BEING MEDICALLY MANAGED WITH ANTICOAGULANT THERAPY (WARFARIN). LABORATORY VALUES ON THE DAY OF ADMISSION SHOWED AN INR OF 3.49, APTT OF 57.4S AND PT OF 16%. THE DIAGNOSIS INDICATED THAT THE PATIENT HAD AN ISCHEMIC STROKE WITH SEQUELA (PERSISTENT DISABILITY LEFT SIDE HEMIPLEGIA). IN VIEW OF THE SITUATION, THE THERAPY WAS ONLY CONSERVATIVE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF IMPLANT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016, THE PATIENT REQUIRED THE PLACEMENT OF EXTRACORPOREAL RIGHT HEART SUPPORT DUE TO BIVENTRICULAR FAILURE. PRE-IMPLANT, THE PATIENT HAD BEEN ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) DUE TO CARDIOGENIC SHOCK. ON POST-LVAD IMPLANT DAY 4, THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR THROMBOTIC MASS EXTRACTION IN THE RIGHT VENTRICLE AND A NEW RIGHT SIDED BLOOD PUMP CIRCUIT WAS PLACED. A SPECIFIC CAUSE FOR THE THROMBOTIC MASS IN THE RIGHT VENTRICLE WAS UNKNOWN. THE EXTRACORPOREAL CIRCUIT SUPPORTING THE RIGHT VENTRICLE REPORTEDLY FUNCTIONED AS INTENDED AND WAS ONLY EXCHANGED DUE TO A CHANGE IN THE CANNULATION SITES. AFTER SEVERAL ATTEMPTS TO WEAN THE PATIENT, THE RIGHT VENTRICULAR EXTRACORPOREAL SUPPORT WAS DISCONTINUED ON (B)(6) 2016. THE PATIENT ALSO EXPERIENCED INFECTION OF UNKNOWN ORIGIN IN THE POSTOPERATIVE PHASE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME ON LVAD SUPPORT. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH LEFT SIDE HEMIPLEGIA. THE SYMPTOMS REPORTEDLY STARTED THE DAY BEFORE; HOWEVER, THE PATIENT DID NOT IMMEDIATELY PRESENT TO THE HOSPITAL. AT THE TIME OF THE EVENT, THE PATIENT WAS BEING MEDICALLY MANAGED WITH ANTICOAGULANT THERAPY (WARFARIN). THE DIAGNOSIS WAS AN ISCHEMIC STROKE WITH PERSISTENT LEFT SIDE HEMIPLEGIA. UNSPECIFIED, ¿CONSERVATIVE THERAPY¿ WAS PROVIDED. THE PATIENT THEN DEVELOPED HEMATURIA WITH ALTERATION OF LIVER ENZYMES AND PLASMA FREE HEMOGLOBIN LEVELS. ON (B)(6) 2017, THE PATIENT¿S LABORATORY VALUES WERE: LACTATE DEHYDROGENASE WAS ABOVE THE CUT OFF AND COULD NO LONGER BE MEASURED, PLASMA-FREE HEMOGLOBIN WAS 304 MG/DL, AND THE HEMOGLOBIN WAS 10.2 G/DL. A TRANS-THORACIC ECHOCARDIOGRAM FOUND THE LEFT VENTRICLE WAS NOT UNLOADING PROPERLY. AN LVAD PUMP EXCHANGE WAS SCHEDULED FOR THE FOLLOWING DAY; HOWEVER, THE PATIENT'S CONDITION RAPIDLY DETERIORATED AND VA ECMO WAS INITIATED. DESPITE VA ECMO AND FULL INOTROPIC SUPPORT, THE PATIENT EXPIRED ON (B)(6) 2017 DUE TO MULTIORGAN FAILURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868706 THORATEC CENTRIMAG RVAS RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE THORATEC SWITZERLAND GMBH 201-90001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R