BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® BIOPROSTHESIS

    MDR report key: 2823159 · Received November 7, 2012

    Report

    Report Number
    2015691-2012-18617
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 2, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. PATIENT TOOK POSSESSION OF THE DEVICE AND WILL NOT RELEASE THE DEVICE NOR ANY REPORTS. THE DHR IS CURRENTLY IN PROGRESS. NO INFECTION OR ENDOCARDITIS WAS REPORTED FOR THIS PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; HOWEVER, PICTURES HAVE BEEN PROVIDED BY THE HOSPITAL AND ARE CURRENTLY UNDER REVIEW TO SEE IF AN ASSESSMENT CAN BE MADE.

    Description of Event or Problem · 1

    REPORTEDLY, A 2625-23MM AORTIC VALVE WAS EXPLANTED AFTER APPROXIMATELY 4 YEARS 7 MONTHS (55.27 MONTHS) DUE TO REGURGITATION. THE CUSTOMER REPORTED: PATIENT IMPLANT A CEBP 4 YEARS AGO IN ANOTHER HOSP [NAME REDACTED], (B)(6) 2012, GO TO [HOSPITAL NAME REDACTED] TO CHECK BODY DUE TO UNCOMFORTABLE. AFTER CHECKING, FOUND VALVE LEAFLETS ARE BROKEN. SO [HOSPITAL NAME REDACTED] MADE DECISION WITH PATIENT TO EXPLANT CEBP AND CHANGED IT TO A MECHANICAL VALVE. PATIENT TOOK VALVE AWAY AND CLAIMED WILL GO BACK TO LOOK FOR [HOSPITAL NAME REDACTED]. DEVICE WILL NOT BE RETURNED. PATIENT TOOK POSSESSION OF THE DEVICE. NO MEDICAL / MEDICATIONS RECORDS WILL BE PROVIDED. PATIENT HAS NOT GIVEN CONSENT. PICTURES OF THE DEVICE WERE MADE AVAILABLE BY THE HOSPITAL. PORCINE VALVE WAS REPLACED WITH A MECHANICAL VALVE (MAKE AND MODEL UNKNOWN). NO ECHOCARDIOGRAPHY WILL BE MADE AVAILABLE. NO REPORT OF INFECTION OR ENDOCARDITIS FOR THIS PATIENT PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2625 R-07K2001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R