BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 6058266 · Received October 26, 2016

    Report

    Report Number
    2015691-2016-03176
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED AS NO SERIAL NUMBER WAS PROVIDED. PARTIAL OR TOTAL OCCLUSION OR OBSTRUCTION OF THE CORONARY OSTIA IS A RECOGNIZED COMPLICATION OF AN AORTIC VALVE REPLACEMENT. IT IS TYPICALLY THE RESULT OF A TECHNICAL ERROR DURING VALVE IMPLANT AND NOT RELATED TO A PRODUCT MALFUNCTION. HOWEVER, PARTIAL OR TOTAL OCCLUSION OF THE OSTIA, IF UNRECOGNIZED, CAN RESULT IN ANGINA, MYOCARDIAL INFARCTION, ACUTE PERI-OPERATIVE RIGHT, LEFT OR BI-VENTRICULAR DYSFUNCTION AND/OR DEATH. IN THIS CASE, PATIENT'S ANATOMICAL VARIANCE AND OPERATIONAL CONTEXT MOST LIKELY CONTRIBUTED TO THIS EVENT. 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

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT COMPLETED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY NOR WAS ONE CONFIRMED THROUGH INVESTIGATION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT EXPIRED AFTER RECEIVING A 19MM EDWARDS BIOPROSTHETIC VALVE DUE TO OBSTRUCTION OF THE CORONARY OSTIA. THE SURGEON REPORTED THAT HE USED CONTINUOUS SUTURE TECHNIQUE DURING IMPLANTATION OF THE 19MM AORTIC VALVE. IMMEDIATELY AFTER POST-OPERATIVE, THE PATIENT SHOWED SIGNS OF ST CHANGES AND ANGIOPLASTY WAS PERFORMED WHICH WAS UNSUCCESSFUL. THE PATIENT'S CONDITION DECLINED AND EXPIRED. THE SURGEON BELIEVES THAT IN THIS CASE, THE PATIENT HAD A SMALL AORTIC ROOT AND THE CORONARY OSTIA WAS NEAR THE ANNULUS. THE SURGEON REPORTED THAT IN OTHER CASES, HE HAS IMPLANTED SIMILAR TYPE OF PRODUCT SUPRA ANNULARLY USING CONTINUOUS SUTURE TECHNIQUE WITH NO COMPLICATIONS. SURGEON AFFIRMS THAT SUPRA-ANNULAR VALVE IS MORE INCLINED TO RISE POSSIBLY OCCLUDING THE CORONARY OSTIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708220 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX19MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death