BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 4336728 · Received December 5, 2014

    Report

    Report Number
    9612515-2014-00017
    Event Type
    Death
    Date Received
    December 5, 2014
    Date of Event
    July 30, 2014
    Report Date
    December 4, 2014
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K952293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE GRAFT HAS NOT BEEN RETURNED TO VASCUTEK LTD., FOR ANALYSIS. IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED. A REVIEW OF THE RETAINED MANUFACTURING RECORDS AND THE ASSOCIATED PROCESSES HAS BEEN COMPLETED. A REVIEW OF THE STERILISATION PROCESS AND RESULTS HAS BEEN COMPLETED. RESULTS: NO RESULTS ARE AVAILABLE AS NO DEVICE HAS BEEN RETURNED TO VASCUTEK FOR ANALYSIS. REVIEW OF THE RETAINED MANUFACTURING AND STERILISATION RECORDS HAS IDENTIFIED NO ABNORMALITIES. CONCLUSIONS: VASCUTEK ARE UNABLE TO CONFIRM THE COMPLAINT AS NO DEVICE HAS BEEN RETURNED TO VASCUTEK FOR ANALYSIS. NO DEFINITIVE CONCLUSION IS AVAILABLE. RHIZOPUS IS AN ENVIRONMENTAL FUNGUS WHICH THRIVES IN ROTTING VEGETATION. VASCUTEK HAS NO HISTORICAL EVIDENCE OF THIS FUNGUS RECORDED THROUGH OUR ENVIRONMENTAL MONITORING PROGRAMME. THIS INCIDENT REPORT HAS BEEN SUBMITTED WITHIN 30 DAYS, AS INITIAL INVESTIGATIONS INDICATED THAT THE EVENT WAS NOT REPORTABLE. HOWEVER, SUBSEQUENT INVESTIGATIONS HAVE FOUND THAT THIS WAS A REPORTABLE EVENT AND THAT THE REPORTING SITE HAD ALSO REPORTED THIS EVENT TO THE FDA. VASCUTEK HAS RAISED AN NCR FOR FAILING TO REPORT THIS INCIDENT IN A TIMELY MANNER.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: ON (B)(6) 2014, AN ELECTIVE AORTIC PROCEDURE (AVR/TUBE GRAFT REPLACEMENT) OF THE AORTA WAS COMPLETED AT (B)(6), A VASCUTEK MANUFACTURED GELWEAVE STRAIGHT GRAFT WAS IMPLANTED; HOWEVER, DURING THE PROCEDURE, IT BECAME APPARENT THAT THE NATIVE HEART VALVE COULD NOT BE SALVAGED; THUS A MEDTRONIC VALVE WAS IMPLANTED IN COMBINATION. PT WAS RELEASED FROM HOSP. ON (B)(6) 2014, THE PT WAS IN (B)(6), THE PT DEVELOPED A FEVER AND WORD FINDING DIFFICULTIES, AND WAS ADMITTED TO THE EMERGENCY ROOM AT (B)(6). A HEAD CT SCAN REVEALED AN ACUTE SUBARACHNOID HAEMORRHAGE AND A CTA OF THORAX SHOWED A MASS IN THE AREA OF THE REPLACED VALVE. ON (B)(6) 2014, THE PT UNDERWENT SURGERY AT THE (B)(6) TO REMOVE AND REPLACE THE ASCENDING AORTIC GRAFT AND VALVE. IT APPEARED DURING SURGERY THAT THE GRAFT HAD A FUNGAL INFECTION PRESENT, WHICH WAS LATER IDENTIFIED AS RHIZOPUS. THE (B)(4) MANUFACTURED GRAFT AND VALVE WERE EXPLANTED AND REPLACED WITH DEVICES FROM UNCONFIRMED MANUFACTURERS (GRAFT AND VALVE). POST OPERATIVELY ((B)(6) 2014), THE PT HAD SOME REMAINING INFECTION BUT WAS RECOVERING WELL. ON (B)(6) 2014, THE PT DIED. (B)(4) ARE CURRENTLY ATTEMPTING TO OBTAIN REDACTED PT MEDICAL RECORDS, POST-MORTEM REPORT AND CT SCANS FROM (B)(6), TO AID OUR INVESTIGATIONS TO DETERMINE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786532 GELWEAVE GELWEAVE STRAIGHT DSY VASCUTEK LTD. GELWEAVE 310719

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R