BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 6792284 · Received August 14, 2017

    Report

    Report Number
    2015691-2017-02443
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 12, 2017
    Report Date
    July 21, 2017
    Manufacturer
    DYE
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEERING EVALUATION WAS PERFORMED AND IT IS POSSIBLE THAT THE PARTICULATE CONTACTED THE VALVE AFTER THE JAR WAS OPENED BY THE CUSTOMER. HOWEVER, THE SOURCE OF THE PARTICULATE COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    PER ENGINEERING EVALUATION, FMEA LINE IS APPROPRIATE, AND LABELING IS ADEQUATE. IT IS POSSIBLE THAT THE PARTICULATE CONTACTED THE VALVE AFTER THE JAR WAS OPENED BY THE CUSTOMER. HOWEVER, THE SOURCE OF THE PARTICULATE COULD NOT BE CONCLUSIVELY DETERMINED. TREND IS IN CONTROL. BASED ON DHR REVIEW AND MONTHLY PREVENTIVE MAINTENANCE FORMS, THERE WAS NO RELATED NON-CONFORMANCE OR ABNORMALITY THAT COULD LEAD TO THE COMPLAINT. A REVIEW OF THE PRODUCT-CONTACT SURFACES DURING PRELIMINARY PACKAGING WAS PERFORMED AND THERE IS NO SIMILAR MATCH BETWEEN THE BLACK PARTICULATES FOUND ON THE VALVE WITH THE PRODUCT-CONTACT SURFACES IN THE MANUFACTURING ENVIRONMENT. THERE ARE MULTIPLE DOWNSTREAM MITIGATION'S AND CONTROLS IN-PLACE TO VERIFY FOR NO PARTICULATE MATTER ON VALVES. IN ADDITION, THE PRELIMINARY PACKAGING STATIONS ARE FURTHER ENHANCED TO 3X MAGNIFICATION LENS SINCE JULY 2017 TO IDENTIFY AND REMOVE PARTICULATES ON VALVES. SINCE THERE IS NO CONFIRMED MANUFACTURING NON-CONFORMANCE'S AND THIS IS AN ISOLATED COMPLAINT INCIDENT, AWARENESS TRAININGS AND PERFORMANCE COACHING WERE PROVIDED TO THE OPERATORS/INSPECTORS AND CORRECTIVE ACTION IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF UNUSUAL MARK/STAIN ON THE UNDERSIDE WAS CONFIRMED DUE TO PARTICULATES FOUND. VALVE WAS EXAMINED PRIOR TO DECONTAMINATION. THREE BLACK PARTICULATES WERE FOUND; ONE ON THE INFLOW SIDE OF EACH LEAFLET. THE LARGER PARTICULATE(A) MEASURED APPROXIMATELY 1MM, AND PARTICULATES B AND C WERE LESS THAN 1MM. THE VALVE WAS RINSED TWO TIME USING SALINE SOLUTION AS INSTRUCTED PER IFU. THE PARTICULATES REMAINED ATTACHED TO THE LEAFLETS POST CLINICAL RINSE. THE VALVE REMAINED ATTACHED TO THE HOLDER. SUTURE HOLES WERE NOT OBSERVE ON THE SEWING RING. THE ID TAG HAD BEEN REMOVED AND WAS NOT RETURNED. X-RAY DEMONSTRATED WIRE FORM INTACT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. IT IS STANDARD OF CARE AND PRESCRIBED IN THE IFU THAT VALVES AND PATCHES UNDERGO A SERIES OF EXTENSIVE RINSES DURING THE PREPARATION PHASE PRIOR TO IMPLANT IN THE PATIENT. THIS RINSE PROCESS IS REQUIRED AS THE VALVES AND PATCHES ARE STORED IN GLUTARALDEHYDE. ACCESSORIES ARE ALSO TYPICALLY RINSED PRIOR TO USE. IT IS POSSIBLE, DURING THIS STANDARD / MANDATORY DEVICE PREPARATION, FIBERS OR PARTICULATE MAYBE OBSERVED. THERE ARE INHERENT TISSUE FIBERS ON THE ¿ROUGH¿ SURFACE OF THE PERICARDIAL TISSUE THAT AT TIME SCAN BE DIFFICULT TO DISTINGUISH FROM PARTICULATE. THE RINSE PROCESS SHOULD REMOVE ALL PARTICULATE. AS A RESULT, SMALL AMOUNTS OF PARTICULATE ARE HIGHLY UNLIKELY TO ENTER THE PATIENT AND CAUSE INJURY. THERE ARE CASES, HOWEVER, WHERE THE PARTICULATE CAN BE PARTIALLY EMBEDDED IN OR ATTACHED TO THE LEAFLET OR VALVE. IF THE PARTICULATE CAN BE RINSED, THE POTENTIAL FOR INJURY TO THE PATIENT IS REMOTE. IF THE PARTICULATE COULD BE NOT REMOVED DURING THE RINSING PROCESS, AND THE VALVE WAS USED IN A PATIENT, THERE IS A POTENTIAL FOR THE PARTICULATE TO ENTER THE PATIENT AND EMBOLIZE. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE PARTICULATES WERE EVALUATED BY CHEMISTRY AND THE FOLLOWING FINDINGS WERE IDENTIFIED: IR SPECTRUM OF THE UNKNOWN PARTICLE "A" SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO ACETYL COPOLYMER LIKE MATERIAL. DUE TO LOW ABSORBANCE ENERGY AND NO SIGNIFICANT IR FINGER PRINTS WERE FOUND; THEREFORE, UNKNOWN PARTICLE "B" CANNOT BE IDENTIFIED. THE IR SPECTRUM OF THE UNKNOWN PARTICLE "C" SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYSTYRENE BUTADIENE LIKE MATERIAL.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A 27MM VALVE WAS OBSERVED TO HAVE UNUSUAL MARK/STAIN ON THE UNDERSIDE WHICH COULD NOT BE REMOVED BEFORE RINSING. THE VALVE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573414 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE DYE 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1