BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONX AORTIC CONFORM EXT 23

    MDR report key: 7068701 · Received November 29, 2017

    Report

    Report Number
    1649833-2017-00087
    Event Type
    Death
    Date Received
    November 29, 2017
    Date of Event
    February 19, 2017
    Report Date
    February 6, 2018
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED SO NO DIRECT OBSERVATION CAN BE MADE. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE MANUFACTURING RECORDS FOR THE ONXACE-23, (SN) (B)(4) 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. ONXACE-23 SN (B)(4) IMPLANTED (B)(6) 2017. AN IMPLANT REGISTRATION CARD WAS NOT RECEIVED. PACEMAKER IMPLANTED (B)(6) 2017. PATIENT DIED (B)(6) 2017 (ONE MONTH POST-IMPLANT). ¿OFFICIAL CAUSE OF DEATH¿ WAS GLOBAL HYPOXIC BRAIN INJURY; ATTRIBUTED TO THROMBOSIS OF MECHANICAL AORTIC VALVE ALTHOUGH WE DO NOT HAVE ANY OFFICIAL MEDICAL REPORT SUCH AS AN ECHOCARDIOGRAM OR AUTOPSY TO SUBSTANTIATE THIS DEDUCTION. REPORT FROM THE FIELD SAYS DEATH DUE TO THROMBUS LEADING TO BLOCKED VALVE LEAFLET; RESULT OF INR MISMANAGEMENT; NO FAULT OF VALVE. PATIENT ALSO REPORTED AS HAVING PROTHROMBOTIC TENDENCY AND A HISTORY OF MULTIPLE DEEP VEIN THROMBOSES (DVTS). PREVIOUS BELOW LEFT KNEE AMPUTATION REQUIRED MULTIPLE SURGERIES. THIS IS A PROBABLY THROMBOSED AORTIC ON-X VALVE DUE TO INADEQUATE ANTICOAGULATION THERAPY. RECOMMENDED INR THERAPY FOR THE FIRST 3 MONTHS POST-IMPLANTATION IS 2.0 ¿ 3.0. PER THE RECORDS PROVIDED, THIS PATIENT¿S INR DID NOT EXCEED 1.3 AT ANY TIME PRIOR TO THE PATIENT¿S DEATH. THROMBOSIS AND DEATH ARE RARE BUT RECOGNIZED RISKS OF PROSTHETIC AORTIC VALVE REPLACEMENT. IN A STUDY OF 184 ON-X AORTIC PATIENTS, THERE WERE NO THROMBOSED VALVES, BUT 4 DEATHS IN THE EARLY POSTOP PERIOD (LESS THAN 30 DAYS) [INSTRUCTIONS FOR USE]. OBJECTIVE PERFORMANCE CRITERIA REPORT AN HISTORICAL THROMBOSIS INCIDENCE OF 0.8% PER VALVE-YEAR FOR ALL RIGID PROSTHETIC VALVES [ISO (B)(4)]. PROBABLE THROMBOSIS OF PROSTHETIC AORTIC VALVE DUE TO INSUFFICIENT ANTICOAGULATION THERAPY LEADING TO PATIENT DEATH VIA BRAIN HYPOXIA.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORT, "DEATH OF PATIENT DUE TO THROMBUS LEADING TO BLOCKED VALVE LEAFLET. RESULT OF MISMANAGEMENT OF INR DURING PACEMAKER IMPLANT, POST ONX IMPLANT. CLINICAL CONCLUSION - NO FAULT OF VALVE." DATE OF IMPLANT: (B)(6) 2017. INDICATION FOR ON-X VALVE IMPLANT: PATIENT PREFERENCE MECHANICAL VALVE. SERIAL NUMBER OF ONXACE-21:(B)(4)[SERIAL NUMBER FOUND TO BE INVALID SO IT WILL BE LEFT BLANK]. DATE OF PACEMAKER IMPLANT: (B)(6) 2017. DATE OF DEATH: (B)(6) 2017. OFFICIAL CAUSE OF DEATH: GLOBAL HYPOXIC BRAIN INJURY, THROMBOSIS OF MECHANICAL AORTIC VALVE, BICUSPID AORTIC VALVE WITH CRITICAL STENOSIS (OPERATED ON (B)(6) 2017), COMPLETE HEART BLOCK. PATIENT COMORBIDITIES: LEFT BELOW KNEE AMPUTATION DUE TO CONGENITAL ANKLE DEFORMITY REQUIRING MULTIPLE OPERATIONS, MULTIPLE DVTS [DEEP VEIN THROMBOSIS]. HISTORIC RECORD OF INR [INTERNATIONAL NORMALIZED RATIO] PROCEEDING AND AT TIME OF DEATH: INR WAS 1.1 ON (B)(6) 2017, 1.2 ON (B)(6) 2017, AND THEN 1.2-1.3 TILL TIME OF DEATH. 1.2 ON (B)(6) 2017. ADDITIONAL INFORMATION REGARDING CAUSE OF SUBTHERAPEUTIC INR DURING PACEMAKER IMPLANT: PATIENT HAD PROTHROMBOTIC TENDENCY. IV [INTRAVENOUS] HEPARIN WAS HOLD FROM 12-8 PM DURING PPM [PERMANENT PACEMAKER] INSERTION DAY.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORT, "DEATH OF PATIENT DUE TO THROMBUS LEADING TO BLOCKED VALVE LEAFLET. RESULT OF MISMANAGEMENT OF INR DURING PACEMAKER IMPLANT, POST ONX IMPLANT. CLINICAL CONCLUSION - NO FAULT OF VALVE." DATE OF IMPLANT: (B)(6) 2017. INDICATION FOR ON-X VALVE IMPLANT: PATIENT PREFERENCE MECHANICAL VALVE. SERIAL NUMBER OF ONXACE-23: (B)(4). DATE OF PACEMAKER IMPLANT: (B)(6) 2017. DATE OF DEATH: (B)(6) 2017. OFFICIAL CAUSE OF DEATH: GLOBAL HYPOXIC BRAIN INJURY, THROMBOSIS OF MECHANICAL AORTIC VALVE, BICUSPID AORTIC VALVE WITH CRITICAL STENOSIS (OPERATED ON (B)(6) 2017), COMPLETE HEART BLOCK. PATIENT COMORBIDITIES: LEFT BELOW KNEE AMPUTATION DUE TO CONGENITAL ANKLE DEFORMITY REQUIRING MULTIPLE OPERATIONS, MULTIPLE DVTS [DEEP VEIN THROMBOSIS]. HISTORIC RECORD OF INR [INTERNATIONAL NORMALIZED RATIO] PROCEEDING AND AT TIME OF DEATH: INR WAS 1.1 ON (B)(6) 2017, 1.2 ON (B)(6) 2017, AND THEN 1.2-1.3 TILL TIME OF DEATH. 1.2 ON (B)(6) 2017. ADDITIONAL INFORMATION REGARDING CAUSE OF SUBTHERAPEUTIC INR DURING PACEMAKER IMPLANT: PATIENT HAD PROTHROMBOTIC TENDENCY. IV [INTRAVENOUS] HEPARIN WAS HOLD FROM 12-8 PM DURING PPM [PERMANENT PACEMAKER] INSERTION DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848327 ONX AORTIC CONFORM EXT 23 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Death