BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING

    MDR report key: 1860701 · Received October 7, 2010

    Report

    Report Number
    2015691-2010-14173
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = UNSUCCESSFUL RING REPAIR.DEVICE NOT RETURNED.MULTIPLE ATTEMPTS HAVE BEEN MADE TO CLARIFY THE REPORTED EVENT AND OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION IS ONGOING.THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT DEVELOPED A SEPTAL BREAKDOWN WHILE USING THE BC3020 NASAL PRONGS AND REQUIRED A PLASTIC SURGERY CONSULT. (B)(6), A RESPIRATORY THERAPIST SUPERVISOR FROM THE HOSPITAL REPORTED THAT A BC303 BONNET AND BC182 (100MM) NASAL TUBING WAS USED ON AN ACTIVE (B)(6) INFANT. THE HOSPITAL STATED THAT THEY OBSERVED A 2MM GAP BETWEEN THE NASAL PRONG AND SEPTUM. THE SEPTUM OF THE PATIENT BECAME RED AND SUBSEQUENTLY ERODED. SEPTAL DAMAGE WAS OBSERVED EIGHT DAYS AFTER USE, FROM (B)(6) 2010, AND THAT THEY WERE USING A CANNULAIDE TO OBTAIN A BETTER SEAL. THE INFANT WAS NOT INTUBATED AND NO OTHER TUBES WERE ATTACHED. THE HOSPITAL FURTHER REPORTED THAT THEY CONSIDERED THE LENGTH OF TIME THE INFANT WAS USING THE PRONGS TO BE A FACTOR IN THE SEPTUM DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO A FAILED RING REPAIR. THE FOLLOWING WAS LEARNED FROM THE HOSPITAL CONTACT VIA EMAIL, "WE PUT A 4450/M32MM IN PATIENT, THE REPAIR WASN'T ADEQUATE PER TEE, SO THEY REMOVED IT AND PUT IN A MECHANICAL VALVE... NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-10F1429

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention