BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2802123 · Received October 23, 2012

    Report

    Report Number
    2015691-2012-18526
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS APPROVED TO UNDERGO A VALVE IN VALVE PROCEDURE AS TREATMENT FOR THE REPORTED STENOSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE ONLY INFORMATION PROVIDED IS THAT THE PATIENT WAS DIAGNOSED WITH BIOPROSTHETIC VALVE STENOSIS AFTER AN IMPLANT DURATION OF 13 YEARS, AND NO INTERVENTION HAS BEEN SCHEDULED OR PERFORMED. BIOPROSTHETIC VALVE STENOSIS CAN BE DUE TO PATIENT FACTORS AS WELL AS INTRINSIC PROPERTIES OF THE VALVE ITSELF. NO PATIENT MEDICAL HISTORY WAS PROVIDED FOR THIS EVENT. ADDITIONAL ATTEMPTS WILL BE PERFORMED TO OBTAIN INFORMATION REGARDING THE STATUS OF THE IMPLANTED VALVE, AND PATIENT'S CONDITION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO INFORMATION PROVIDED TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THE PATIENT WAS APPROVED TO UNDERGO A TRANSCATHETER VALVE IN VALVE PROCEDURE INSIDE THE DEGENERATED ONE, SCHEDULED FOR (B)(6) 2012. PATIENT CASE PRESENTATION INDICATES THIS IS A (B)(6) FEMALE, SYMPTOMATIC SEVERE AS, WORSENING DYSPNEA ON EXERTION, SURGICAL AVR 1999 21 MM C-E BOVINE VALVE, NYHA CLASS II, FRAILTY, TTE 9/19: EF 77%, AVA 0.63 CM², MEAN GRAD 55.7MMHG, PEAK GRAD 93 MMHG VMAX 4.82 M/S, TEE SHOWS DEGEN. THICKENED LEAFLETS, REDUCED LEAFLET MOBILITY, TRACE-MILD AI WITHOUT ROCKING OR PARAPROSTHETIC LUCENCY DILATED ANEURYSM ASCENDING AORTA MR MILD, TR SEVERE, RSVP 51.4 MMHG, HTN, CAD NOT SIGNIFICANT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CLINICAL SPECIALIST THAT A PATIENT WITH A MODEL 2800-23MM AORTIC VALVE PRESENTED SYMPTOMS OF STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 13 YEARS. THE STENOSIS WAS REVEALED ON A ECHO PERFORMED DURING A CLINICAL WORK UP AS THE PATIENT IS BEING EVALUATED FOR INCLUSION INTO THE CLINICAL TRIAL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE TYPE OF INTERVENTION PERFORMED, IF ANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800 9K1414

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L