BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD CUFF

    MDR report key: 165783 · Received May 5, 1998

    Report

    Report Number
    2648612-1998-00010
    Event Type
    Injury
    Date Received
    May 5, 1998
    Date of Event
    April 6, 1998
    Report Date
    May 5, 1998
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 3/10/1997, DR. IMPLANTED 3 MM MITRAL ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 31M-101), PT HAD HISTORY OF RHEUMATIC MITRAL STENOSIS, RHEUMATOID ARTHRITIS, AND PULMONARY FIBROSIS. PT'S NATIVE MITRAL VALVE WAS SEVERELY STENOTIC AND CALCIFIED. ON 4/6/1998, DR. EXPLANTED THIS VALVE DUE TO LEAFLET IMMOBILITY. VALVE HAD BEEN IMPLANTED IN ANATOMICAL POSITION, AND ANTERIOR LEAFLET WAS NOTED TO BE IMMOBILE. SURGEON BELIEVED PT WAS FOLLOWING ANTICOAGULANT REGIME. THERE WAS THROMBUS AND "SOME" PANNUS PRESENT ON VALVE AT TIME OF EXPLANT. ANOTHER 31 MM MITRAL ST. JUDE MEDICAL MECHANICAL HEART VALVE WAS THEN IMPLANTED, AND PT'S POSTOPERATIVE HEALTH STATUS WAS REPORTED AS STABLE. RESULTS OF INVESTIGATION: VALVE WAS RECEIVED IN ST. JUDE MEDICAL VALV DIV FER ANALYSIS LAB IN ST. JUDE MEDICAL PRODUCT RETURN KIT, SUBMERGED IN LIQUID SOLUTION. SEWING CUFF WAS OFF-WHITE IN COLOR, AND CONTAINED SEVERAL CUTS ANS SUTURES. SMALL AMOUNT OF WHITISH TISSUE WAS ALSO OBSERVED ON SEWING CUFF. BOTH LEAFLETS WERE OBSERVED TO OPEN AND CLOSE; HOWEVER, COMPLETE MOBILITY REQUIRED SMALL AMOUNT OF MANUAL FORCE. THIS RESISTANCE TO MOBILITY WAS MOST LIKELY DUE TO PRESENCE OF DRIED, WHITISH SUBSTANCE LODGED IN RECESSED PIVOT AREAS. GRANULAR, PARTICULATE SUBSTANCE, MOST LIKELY BLOOD AND/OR BODY FLUIDS, COVERED CARBON SURFACES OF VALVE. VALVE WAS CHEMICALLY STERIIZED AND FORWARDED TO A M.D.,PH.D., INDEPENDENT PATHOLOGIST AT FACILITY, FOR GROSS MORPHOLOGICAL EXAMINATION. SECOND DR. STATED THAT AT TIME OF HIS EXAMINATION, MOST OF TISSUE ATTACHED TO SEWING CUFF WAS FIBROUS (COLLAGEN), WHICH HAD DEGREEE OF CELLULARITY (MYOFIBROBLASTIC CELLS), INDICATING ONGOING FORMATION AS SEEN WITH DEVELOPMENT OF PANNUS. SURFACE OF THIS TISSUE WHICH WAS AWAY FROM BLOODSTREAM AND IN CONTACT WITH SEWING CUFF FABRIC, CONTAINED DISTINCTLY YOUNG FOBROUS TISSUE WITH MOR CELLULARITY AND LESS DEFINITIVE FIBROUS STROMA. TOGETHTER WITH MUCH OF THIS FIBROUS TISSUE WAS RECENT FIBRIN THROMBUS WITH SOME EVIDENCE OF EARY STAGES OF ORGANIZATION MANIFESTED BY ALTERATION OF FIBRIN, AND INGROWTH OF FIBROBLASTIC AND/OR MYOFIRBOBLASTIC CELLS WITH FOCUS OF NEARLY MATURE FIBROUS TISSUE. SMALL AMOUT OF TISSUE OBTAINED FROM RECESSED PIVOT AREAS WAS IDENTIFIED PRIMARILY AS ALTERED FIBRIN WITH MINIMAL EVIDENC OF ORGANIZATION. THIS INDICATED A PROCESS, AT THIS SITE ONLY, IN ORDER OF ONE TO THREE DAYS OF AGE. THIS MAY HAVE OCCURRED JUST PRIOR TO EXPLANT OR AS EX VIVO EVENT, PRIOR TO PLACING VALVE IN FORMALIN TO RETURN IT FOR ANALYSIS. SPECIAL STAINS FOR MICROORGANISMS (GRAM AND GMS) WERE NEGAVIET. SECOND DR. CONCLUDED THAT APPARENTLY RECENT THROMBUS OBSERVED IN RECESSED PIVOT AREAS WAS RESPONSIBLE FOR RESTRICTED LEAFLET MOBILITY, AND ONGOING FIBROSIS OF TISSUE ON SEWING CUFF SUGGESTED PANNUS DEVELOPMENT. VALVE WAS THEN CLEANED, AND SEWING CUFF WAS REMOVED. VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON SURFACES OF LEAFLEST AND ORIFICE.

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO LEAFLET IMMOBILITY. THE VALVE WAS IMPLANTED IN THE ANATOMICAL POSITION AND THE ANTERIOR LEAFLET WAS IMMOBILE. THE SURGEON BELIEVES THE PT WAS FOLLOWING THE ANTICOAGULANT REGIME. THERE WAS THROMBUS AND "SOME" PANNUS PRESENT ON THE VALVE AT EXPLANT. A 31MM SJM VALVE WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD CUFF Implant MECHANICAL HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 31M-101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention