BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2781311 · Received October 10, 2012

    Report

    Report Number
    2015691-2012-18434
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 14, 2012
    Report Date
    September 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE WAS NOT EXPLANTED, THEREFORE, NO EVALUATION WILL BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS STILL IN PROGRESS. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED RELATED TO THE EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: BASED ON THE HEALTHCARE PROVIDER'S RESPONSE, THIS PATIENT PRESENTED WITH SEVERE SYMPTOMATIC AORTIC STENOSIS AND WAS INOPERABLE FOR OPEN HEART SURGERY AND WITH ACUTE ON CHRONIC SYSTOLIC AND DIASTOLIC HEART FAILURE EXACERBATION. ULTRASOUND SHOWED EVIDENCE OF CRITICAL NARROWING OF THE PROSTHETIC AORTIC VALVE. THEREFORE, IT WAS DECIDED TO PROCEED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT VIA TRANSFEMORAL APPROACH ON THE OLD VALVE. THE PROCEDURE WAS UNCOMPLICATED AND THE PATIENT REPORTEDLY DID WELL. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT EXPLANTED FROM THE PATIENT; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 REPORTED THAT PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS AND 4 MONTHS. UNFORTUNATELY, THE REASON FOR THE RE-OPERATION HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. ANOTHER EDWARDS BIOPROSTHESIS VALVE WAS RE-IMPLANTED IN THE AORTIC POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R