BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X AORTIC ANATOMIC EXT 21

    MDR report key: 10246777 · Received July 8, 2020

    Report

    Report Number
    1649833-2020-00022
    Event Type
    Death
    Date Received
    July 8, 2020
    Report Date
    September 15, 2020
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 AND G3 CHANGED TO ON-X LIFE TECHNOLOGIES, INC. AN ONXANE 21, SN (B)(6), WAS IMPLANTED ON (B)(6) 2015 IN THE AORTIC POSITION OF A 57-YEAR-OLD MALE PATIENT. THE PATIENT'S WIFE REPORTED THE PATIENT'S DEATH AND NOTED THE PATIENT WAS DOING GREAT AT HIS LAST DOCTOR VISIT, BUT A MONTH LATER WAS FOUND DEAD ON HIS BED. THE COMPLAINT ALSO NOTED "THE VALVE PUT US INTO SERIOUS DEBT...I LOST OUR HOME AND HIS CAR BECAUSE I WANTED MY HUSBAND OF 30 YEARS TO LIVE." THE EXACT DATE OF THE PATIENT'S DEATH WAS NOT DETERMINED; HOWEVER, IT IS NOTED THAT THE PATIENT DIED SOMETIME IN 2017. ADDITIONAL INFORMATION WAS PROVIDED BY A CRYOLIFE REPRESENTATIVE, WHO RELAYED PER THE IMPLANTING SURGEON, "THE PATIENT HAD MANY CO-MORBIDITIES, AND HE (THE SURGEON) DID NOT KNOW OF ANY VALVE PROBLEMS." THE CRYOLIFE REPRESENTATIVE STATED THAT THE PATIENT HAD DIED IN HIS SLEEP. THE PATIENT HAD BEEN TO THE CARDIOLOGIST THE WEEK BEFORE AND ALL TESTING WAS WITHIN NORMAL LIMITS. THE ON-X VALVE WAS FUNCTIONING PROPERLY. THE PATIENT HAD A HISTORY OF SEVERE ATHEROSCLEROSIS. THE PATIENT'S WIFE DOES NOT BELIEVE HIS DEATH WAS DUE TO THE ON-X VALVE. THE VALVE WAS NOT RETURNED FOR EVALUATION THUS WE DO NOT HAVE ANY DIAGNOSIS OR FINDINGS TO INDICATE WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE DEATH OF THE PATIENT. ALTHOUGH THERE IS NO EVIDENCE OF VALVE INVOLVEMENT, THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE LISTS DEATH AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT [IFU]. THERE IS INSUFFICIENT INFORMATION TO INDICATE A ROOT CAUSE FOR THE DEATH OF THIS ON-X PATIENT. THERE IS NO INDICATION THAT THE DEATH IS VALVE RELATED. 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 RECEIVED FROM A CRYOLIFE JUNIOR MARKETING COMMUNICATION SPECIALIST, RELAYED THE FOLLOWING PER THE PATIENT'S SPOUSE "MY HUSBAND HAD THIS VALVE PUT IN, IN 2016. HE DIED IN 2017 AT THE AGE OF 59. HIS LAST "DOCTOR'S" VISIT SAID HE WAS DOING GREAT. A MONTH LATER I FOUND HIM DEAD IN OUR BED. THIS VALVE PUT US INTO SERIOUS DEBT, AND WAS IT EVEN WORTH IT???????HIS NAME WAS (B)(6). I LOST OUR HOME "AND" HIS CAR BECAUSE I WANTED MY HUSBAND OF 30 YEARS TO LIVE. THAT'S MY STORY!!!" ADDITIONAL INFORMATION FROM THE IMPLANT REGISTRATION CARD INDICATED THE VALVE WAS IMPLANTED ON (B)(6) 2015.

    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 RECEIVED FROM A CRYOLIFE JUNIOR MARKETING COMMUNICATIONS SPECIALIST, RELAYED THE FOLLOWING PER THE PATIENT'S SPOUSE "MY HUSBAND HAD THIS VALVE PUT IN, IN 2016. HE DIED IN 2017 AT THE AGE OF (B)(6). HIS LAST DOCTORS VISIT SAID HE WAS DOING GREAT. A MONTH LATER I FOUND HIM DEAD IN OUR BED. THIS VALVE PUT US INTO SERIOUS DEBT, AND WAS IT EVEN WORTH IT??????? HIS NAME WAS (B)(6). I LOST OUR HOME A HIS CAR BECAUSE I WANTED MY HUSBAND OF 30 YEARS TO LIVE. THAT'S MY STORY!!! " ADDITIONAL INFORMATION FROM THE IMPLANT REGISTRATION CARD INDICATED THE VALVE WAS IMPLANTED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711039 ON-X AORTIC ANATOMIC EXT 21 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-21

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death