BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2030010 · Received March 25, 2011

    Report

    Report Number
    2015691-2011-15089
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HAS NOT BEEN RETURNED FOR EVALUATION YET. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE HAS NOT BEEN RETURNED AS OF THIS REPORT; NO EVALUATION HAS BEEN PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE RECEIVED OPERATIVE REPORT NOTES THAT THE SUBJECT VALVE WAS CALCIFIED; CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. WITHOUT RETURN OF THE SUBJECT DEVICE, NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED VISUALLY, BY LIGHT MICROSCOPE, AND X-RAY. AS RECEIVED, THE VALVE EXHIBITS HEAVY CALCIFICATION IN THE CUSP AREA OF ALL THREE LEAFLETS. AT THE FREE MARGINS, CALCIFICATION IS MINIMAL TO MODERATE AT LEAFLET 2 AND MODERATE TO HEAVY AT LEAFLET 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. AS RECEIVED, A GAP IS NOTED AT THE COAPTATION REGION. HOST TISSUE IS MODERATE AT THE STENT INFLOW AND MINIMAL TO MODERATE AT STENT OUTFLOW. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. 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. 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. OVERALL, THE INVESTIGATION DID NOT INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS VALVE AS EXPLANTED AFTER AN IMPLANT DURATION OF 45 MONTHS DUE TO AORTIC STENOSIS WITH MODERATELY SEVERE AORTIC INSUFFICIENCY. THE OPERATIVE REPORT STATES, "THE PROSTHETIC AORTIC VALVE WAS FIXED IN A NEARLY CLOSED POSITION WITH VIRTUALLY NO MOBILITY OF ANY OF THE 3 LEAFLETS. THERE WAS RATHER EXTENSIVE CALCIFICATION INVOLVING ALL 3 LEAFLETS...THERE WAS THICK CALCIFICATION AT THE ORIGIN OF THE BRACHIOCEPHALIC VESSELS...EXCISED THE VALVE AND DEBRIDED THE ANNULUS OF LOOSE MATERIAL AND CALCIUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX 6C0452

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R