BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4130487 · Received September 30, 2014

    Report

    Report Number
    2015691-2014-02283
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT THE RETURN OF THE DEVICE OR ADDITIONAL INFORMATION, EDWARDS IS UNABLE TO DRAW ANY CONCLUSIONS AS TO THE REASON FOR PARAVALVULAR LEAK. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS, INCLUDING TECHNIQUE AND PATIENT RELATED FACTORS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, A 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY TWO (2) YEARS AND THREE (3) MONTHS, WAS EXPLANTED DUE TO SEVERE AORTIC PARAVALVULAR LEAK (PVL) AND MODERATE TO SEVERE AORTIC REGURGITATION. THERE WAS A REPORTED VALVE DEHISCENCE OF 120 DEGREES CIRCUMFERENCE OF THE AORTIC VALVE. ADDITIONAL FINDINGS INCLUDED AN EXTREMELY CALCIFIED AORTA AND CALCIFIED/FRAGMENTED AORTIC ROOT AND LEFT/RIGHT MAIN CORONARY BUTTONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 21MM PERICARDIAL VALVE, SEWN INTO A 27MM VALSALVA GRAFT. THE PATIENT ALSO UNDERWENT CABG X2 AND ENDARTERECTOMY OF THE LEFT MAIN CORONARY, AS WELL AS AORTIC ROOT REPLACEMENT. OPERATIVE COMPLICATION INCLUDED INJURY TO THE RIGHT VENTRICLE UPON RETRACTION DURING DISSECTION OF THE HEART. CONSIDERING THE DURATION OF THE SURGERY, THE SURGEON ELECTED TO RESUSCITATE THE PATIENT AND LEAVE THE CHEST OPEN. PER DOCUMENT REVIEW, IT WAS FURTHER LEARNED THAT AN ATTEMPT HAD BEEN MADE PRIOR TO THIS REPLACEMENT TO RESOLVE THE PVL WITH PERCUTANEOUS CLOSURE, UNSUCCESSFULLY. IT WAS LATER REPORTED TO EDWARDS THAT PATIENT HAS EXPIRED. CAUSE OF DEATH HAS NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608573 CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX21MM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 Required Intervention