BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2223629 · Received August 25, 2011

    Report

    Report Number
    2015691-2011-16104
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS THE REASON FOR EXPLANT, OPERATIVE REPORT, AND DEVICE STATUS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT AT THIS TIME. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION WAS RECEIVED. THE OPERATIVE REPORT INDICATES THAT THE PATIENT PRESENTED WITH CRITICAL AORTIC STENOSIS OF HER NATIVE AORTIC VALVE. UPON REMOVAL OF THE NATIVE VALVE, SEVERE CALCIFICATIONS WERE NOTED. THE ANNLUS WAS METICULOUSLY DEBRIDED AND A 21 MM EDWARDS BIOPROSTHETIC VALVE WAS PLACED. AFTER ATTEMPTING TO WEAN THE PATIENT FROM THE HEART-LUNG MACHINE, IT WAS NOTED THAT THERE WAS BLEEDING FROM THE NONCORONARY CUSP AREA AND THE POSTERIOR WALL OF THE AORTA. IT WAS NOT EASILY REPAIRABLE, SO THE DECISION WAS MADE TO GO BACK ON BYPASS. UPON INSPECTION, THERE WAS EVIDENCE OF A TEAR POSTERIORLY BEHIND THE ANNULUS. THEREFORE, THE INITIAL VALVE WAS REMOVED, THE SITE WAS REPAIR WITH A PATCH, AND ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS PLACED (SAME MODEL/SIZE).

    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, IT WAS LEARNED THAT THE AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH ANOTHER SAME MODEL/SIZE VALVE. THE REASON FOR EXPLANTING THE DEVICE HAS NOT BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS WITH THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-11D1322

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R