BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC HEART VALVE WITH CONFORM-X SEWING RING

    MDR report key: 8184208 · Received December 20, 2018

    Report

    Report Number
    1649833-2018-00177
    Event Type
    Death
    Date Received
    December 20, 2018
    Report Date
    February 24, 2019
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE MANUFACTURING RECORDS FOR THE ONXACE-21 SN (SERIAL NUMBER) (B)(4) AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THE INITIAL REPORT INDICATES THAT A POSTOPERATIVE DEATH OCCURRED IN AN ON-X VALVE RECIPIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS IMPLANTED WITH AN ONXACE-21 SN (B)(4), ON (B)(6) 2018. THE ONLY OTHER INFORMATION AVAILABLE WAS THAT THE PATIENT HAD ENDOCARDITIS AND WAS AN IV DRUG ABUSER. HISTORY OF IV DRUG USE INCREASES THE RISK OF INFECTIVE ENDOCARDITIS (IE). REINFECTION OCCURRENCE IS HIGH AS CONTINUED DRUG USE SEEMS TO BE A MAJOR CHALLENGE FOR THIS GROUP. ADDITIONALLY, PREVIOUS EPISODES OF IE INCREASES THE RISK OF A NEW INCIDENT. A DEFINITIVE CAUSE FOR THE PATIENT DEATH CANNOT BE DETERMINED BASED ON THE LIMITED AVAILABLE INFORMATION, HOWEVER, IT IS LIKELY RELATED TO A SEQUELAE OF IV DRUG USE, ENDOCARDITIS, AND THE TRAUMA OF SURGERY. THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE LISTS ENDOCARDITIS AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT AND INCLUDES THE POSSIBILITY OR REOPERATION AND/OR EXPLANTATION AND DEATH. THERE IS NO INDICATION THAT THE REPORTED DEATH IS RELATED TO THE ON-X HEART VALVE. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. NO FURTHER ACTION IS REQUIRED. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THERE WAS A POST-OPERATIVE DEATH.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, THERE WAS A POST-OPERATIVE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023347 AORTIC HEART VALVE WITH CONFORM-X SEWING RING HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE-21

    Patients

    Seq Age Sex Outcome Treatment
    1 Death