BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1912144 · Received December 1, 2010

    Report

    Report Number
    2015691-2010-14465
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. MODEL NUMBER IS UNKNOWN. SERIAL NUMBER WAS NOT PROVIDED. NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE DONE UNTIL THIS INFORMATION IS KNOWN. DEVICE IS CURRENTLY TO BE RETURNED FOR EXAMINATION. PERMISSION HAS BEEN REQUESTED TO DISMANTLE THE DEVICE TO GAIN THE SERIAL NUMBER AFTER THE EVALUATION IS COMPLETED AND THE DHR WILL BE DONE. PATIENT WAS SYMPTOMATIC OF INFECTION; HOWEVER, THE SURGEON INDICATED THAT IT WAS NOT A TYPE A INFECTION (B)(6). THE SOURCE AND TYPE OF INFECTION IS STILL UNKNOWN. ADDITIONAL REQUESTS HAVE BEEN MADE FOR THE DEVICE MODEL NUMBER AND SERIAL NUMBER, PATIENT HISTORY, PATHOLOGY AND OPERATIVE REPORTS. NONE HAVE BEEN RECEIVED TO-DATE. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EVALUATION SUMMARY: AS RECEIVED THE VALVE EXHIBITS MINIMAL TO MODERATE VEGETATION-LIKE GROWTH AT THE INFLOW ASPECT AND THE OUTFLOW ASPECT OF ALL THREE LEAFLETS. THE GROWTH IS MOSTLY LOCATED ALONG THE ATTACHMENT OF THE LEAFLETS. MINIMAL TO MODERATE TO HEAVY HOST TISSUE OVERGROWTH ONTO THE TISSUE AT BOTH ASPECTS. IT ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6-7MM AND ONTO THE TISSUE OUTFLOW BY 4MM. A CUT OUT IN THE SEWING RING ALONG LEAFLET 1 IS EVIDENT, MOST LIKELY DUE TO EXPLANT. THE X-RAY DEMONSTRATES MINIMAL CALCIFICATION. THE VALVE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, THE ENDOCARDITIS FIRST APPEARED APPROXIMATELY FOUR YEARS AFTER IMPLANT. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REPORTED EXPLANTING A DEVICE AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE YEARS (58.70 MONTHS) DUE TO PATIENT SYMPTOMS "DYSPNEA, FEVER, ENDOCARDITIS, AND CARDIAL DECOMPENSATION". THE PATIENT HAD ENDOCARDITIS IN (B)(6) 2009 AND AGAIN IN (B)(6) 2010. THE SURGEON INDICATED THE MITRAL DEVICE HAD DEGENERATED, WAS STENOTIC AND HE EXPLANTED IT ON (B)(6) 2010. AT EXPLANT, THE DEVICE WAS DESCRIBED AS "PART OF THE RING DAMAGED" BUT THERE WAS NO MENTION OF THE ENDOCARDITIS. THE SOURCE AND TYPE OF INFECTION HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 05F037

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R