BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONX MITRAL STANDARD 25

    MDR report key: 15369959 · Received September 7, 2022

    Report

    Report Number
    1649833-2022-00047
    Event Type
    Death
    Date Received
    September 7, 2022
    Date of Event
    July 24, 2019
    Report Date
    November 11, 2022
    Manufacturer
    ARTIVION, INC. ¿ AUSTIN
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. 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 ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.

    Additional Manufacturer Narrative · 0

    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 ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC. ACCORDING TO INITIAL REPORTS, ¿PATIENT WAS A PARTICIPANT IN THE PROSE STUDY. HE HAD A DIAGNOSIS OF RHEUMATIC HEART DISEASE WITH MODERATE MITRAL REGURGITATION, SEVEREPAH, SEVERE TR, LA ANEURYSMALLY DILATED AND REQUIRED MITRAL VALVE REPLACEMENT. HE VOLUNTARILY PARTICIPATED IN THE STUDY BY SIGNING INFORMED CONSENT FORM FOR THE STUDY ON (B)(6) 2015. (B)(6) 2020 ¿ PHONE CALL WAS MADE TO THE PATIENT FOR ENQUIRING ABOUT HIS WELLBEING AND REMINDING HIM OF THE UPCOMING 5 YEARS STUDY FOLLOW-UP (PLANNED FOR (B)(6) 2020). PATIENT¿S ATTENDANT INFORMED THAT HE DIED ON (B)(6) 2019 AT HOME WITHIN FEW MINUTES AFTER SUDDEN ONSET OF BREATHLESSNESS. THE MOST PROBABLE CAUSE OF DEATH IS NOT KNOWN. PATIENT'S HISTORICAL INR (B)(6) 2015 1.21 (B)(6), 2015 (B)(6), 2015 4.36 (B)(6) 2025 4.47 THIS INVESTIGATION IS RELEGATED TO ONXM-25 SN (B)(6) DATE OF EVENT JULY 24, 2019. THE VALVE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONALLY, THIS PATIENT EXPERIENCED AN EVENT 14 NOV 2015. AN INVESTIGATION INTO THE EVENT CAN BE FOUND IN COMPLAINT (B)(4) (MANUFACTURER REPORT NUMBER 1649833-2022-00046). BOTH EVENTS WERE SUBMITTED SIMULTANEOUSLY. THE MANUFACTURING RECORDS FOR THE ONXM-25 SN (B)(6) WERE REVIEWED 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. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. ON (B)(6) 2015 AN APPROXIMATELY 16-YEAR-OLD MALE WAS CONSENTED INTO THE PROSE [PROSPECTIVE RANDOMIZED ON-X VS. SJM MEDICAL EVALUATION] STUDY BY HIS FATHER; WAS RANDOMIZED INTO THE ON-X ARM AND UNDERWENT A MITRAL VALVE REPLACEMENT WITH CONCOMITANT TRICUSPID VALVE REPAIR. THE VALVE IMPLANTED WAS ONXM- 25 SN (B)(6). THE PATIENT HAD A PAST MEDICAL HISTORY OF RHEUMATIC HEART DISEASE WITH MODERATE MITRAL REGURGITATION, SEVERE PAH [PULMONARY ARTERIAL HYPERTENSION], LA [LEFT ATRIUM] ANEURYSMALLY DILATED AND SEVERE TRICUSPID INSUFFICIENCY THAT REQUIRED A MITRAL VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR. ON (B)(6) 2020, WHEN STUDY STAFF CALLED TO REMIND THE PATIENT OF HIS 5 YEAR FOLLOW UP VISIT, THEY WERE INFORMED OF THE PATIENT¿S PASSING ON (B)(6)2019 ((B)(6) DAYS POST IMPLANT). PER THE NOTES PROVIDED, THE PATIENT PASSED AT HOME SUDDENLY, WITHIN A FEW MINUTES, AFTER ONSET OF BREATHLESSNESS, AND NO OTHER INFORMATION IS AVAILABLE. THE LAST FOLLOW UP VISIT WAS CONDUCTED VIA TELEPHONE ON (B)(6) 2019 AND NO COMPLICATIONS WERE REPORTED. HOWEVER, IT WAS ALSO NOTED AT THE 4-YEAR VISIT THAT THE PATIENT WAS ONLY ON COUMADIN AND NO LONGER TAKING ASA AS WAS RECOMMENDED AFTER HE WAS DIAGNOSED WITH A VALVE THROMBOSIS ON (B)(6) 2015. THE LIMITED INFORMATION WE HAVE PROVIDES NO EVIDENCE TO INDICATE WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THIS UNFORTUNATE CLINICAL OUTCOME. 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 RECIPIENT OR WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THIS OUTCOME. NO FURTHER ACTION IS REQUIRED. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. BASED ON THE LIMITED AVAILABLE INFORMATION, A ROOT CAUSE FOR THIS EVENT IS UNKNOWN. ADDITIONALLY, WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. THE MANUFACTURING RECORDS WERE REVIEWED, 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. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK; THEREFORE, A CAPA EVALUATION BY THE CAPA DEPARTMENT IS NOT WARRANTED AT THIS TIME. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H10 - PATIENT HISTORICAL INR SHOULD READ (B)(6), 2015. INITIAL REPORT B5 - PATIENT HISTORICAL INR SHOULD READ (B)(6), 2015.

    Description of Event or Problem · 0

    PATIENT WAS A PARTICIPANT IN THE PROSE STUDY, SUBJECT ID ¿(B)(6)¿. HE HAD A DIAGNOSIS OF RHEUMATIC HEART DISEASE WITH MODERATE MITRAL REGURGITATION, SEVERE PAH, SEVERE TR, LA ANEURYSMALLY DILATED AND REQUIRED MITRAL VALVE REPLACEMENT. 19 MAY 2020 ¿ PHONE CALL WAS MADE TO THE PATIENT ENQUIRING ABOUT HIS WELLBEING AND REMINDING HIM OF THE UPCOMING 5 YEAR STUDY FOLLOW-UP (PLANNED FOR (B)(6) 2020). PATIENT¿S ATTENDANT DISCLOSED PATIENT DIED ON (B)(6) 2019 AT HOME WITHIN A FEW MINUTES AFTER SUDDEN ONSET OF BREATHLESSNESS. THE MOST PROBABLE CAUSE OF DEATH IS NOT KNOWN. THIS INVESTIGATION IS RELEGATED TO ONXM-25 SN (B)(4). PATIENT'S HISTORICAL INR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459164 ONX MITRAL STANDARD 25 HEART-VALVE, MECHANICAL LWQ ARTIVION, INC. ¿ AUSTIN ONXM-25

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Death