BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEFLON FIBER CUFF

    MDR report key: 126629 · Received October 17, 1997

    Report

    Report Number
    2648612-1997-00038
    Event Type
    Injury
    Date Received
    October 17, 1997
    Date of Event
    September 10, 1997
    Report Date
    October 17, 1997
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALE WEAS RECEIVED IN THE MEDICAL HEART VALVE DIVISION FER ANALYSIS LAB IN ST. JUDE MEDICAL PRODUCT RETURN KIT, SUBMERGED IN LIQUID SOLUTION. SEWING CUFF HAD PREVIOUSLY BEEN REMOVED FROM CARBON ORIFICE, PRIOR TO RETURNING VALVE FOR ANALYSIS. SEWING CUFF WAS OFF-WHITE IN COLOR, CONTAINED SEVERAL SUTURES, AND EXHIBITED SOME WHITISH TISSUE. SOME WHITISH-GRAY TISSUE WAS OBSERVED IN RECESSED PIVOT AREAS #2 AND #3; TWO RECESSED PIVOT AREAS WHICH CORRESPOND WITH RIGHT LEAFLET. RIGHT LEAFLET EXHIBITED RESISTANCE TO FULL CLOSURE, WHICH WAS MOST LIKELY DUE TO PRESENCE OF PRVIOUSLY MENTIONED TISSUE IN RECESSED PIVOT AREAS. LEFT LEAFLET ALSO EXHIBITED SMALL AMOUNT OF RESISTANCE TO FREE MOBILITY; HOWEVER, LEFT LEAFLET OPENED AND CLOSED MORE COMPLETELY THAN RIGHT LEAFLET. GRANULAR SUBSTANCE, APPEARING TO BE BLOOD AND/OR BODDY FLUID, COVERED CARBON SURFACES OF VALVE. PATHOLOGIST STATED THAT AT TIME OF HIS EXAMINATION, WHITISH, GLISTENING TISSUE PREVIOUSLY OBSERVED ON DETACHED SEWING CUFF WAS DETERMINED TO BE FIBROUS TISSUE CONSITUTING NORMAL HEALING REACTION. MAJORITY OF THIS TISSUE WAS MATURE COLLAGEN, INDICATING AGE OF FEW MONTHS. RESTRICTION OF LEAFLET MOTION, SPECIFICALLY RIGHT LEAFLET, WAS MOST LIKELY DUE TO PRESENCE AT BOTH PIVOT RECESSES AND EXTENDING SLIGHTLY ONTO BOTH SURFACES OF LEAFLET, OF GRAYISH, SOFT TISSUE COMPATIBLE WITH FIBRIN DEPOSITION. NO INFECTION, NO ORGANIZATION OF THROMBUS ORGANIZATION, AND NO SIGNIFICANT INFLAMMATION WAS PRESENT. VALVE WAS THEN DISASSEMBLED FOR PERFORMANCE TESTING. RESULTS OF PULSE DUPLICATOR TESTING INDICATED VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED THE VALVE OPERATED SATISFACTORILY, WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESTING WAS PERFORMED, AND VALVE MET ALL OF ST. JUDE MEDICAL'S SPECIFICATIONS. LEAFLET AND ORIFICE DIMENSIONS WERE INSPECTED AND VERIFIED TO BE WITHIN ST. JUDE MEDICAL'S SPECIFICATIONS. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS DISPLAYED SURFACE SCRATCH MARK ON BEVEL STRAIGHT EDGE SURFACE OF LEFT LEAFLET NEAR LEFT EAR. ALSO, SMALL SURFACE BLEMISH FEATURE WAS DETECTED ON OUTFLOW SIDE OF RIGHT LEAFLET, NEAR RIGHT EAR. THIS AREA IS ASSOCIATED WITH RIGHT LEAFLET'S MATING SURFACE WITH RECESSED PIVOT AREA #2, WHEN LEAFLET IS IN CLOSED POSITION. ANOTHER SURFACE BLEMISH FEATURE WAS DETECTED ON UPPER WALL OF RECESSED PIVOT AREA #1. THIS AREA IS ASSOCIATED WITH LEFT LEAFLET'S LEFT EAR MATING SURFACE, WHEN LEAFLET IS IN CLOSED POSITION. CARBON COATING THICKNESS MEASUREMENTS CONFORMED WITH REQUIREMENTS SPECIFIED IN ST. JUDE MEDICAL DOCUMENTATION FOR CARBON COATING COMPONENTS AFTER MFG POLISHING OPERATION. CONCLUSION: INFO REVIEWED FROM VALVE'S DEVICE HISTORY RECORD AND ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LAB INDICATED VALVE COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT TIME OF MFR. RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE.

    Description of Event or Problem · 1

    ON 10/28/1996, DR. IMPLANTED A 29 MM MITRAL ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 29MT-103, ON 3/25/1997, THE PT WAS HOSPITALIZED DUR TO MITRAL INSUFFICIENCY. THROMBUS DISSOLUTION WAS PERFORMED SUCCESSFULLY WITH TPA TREATMENT ON 3/27/1997. ON 9/5/1997, PT WAS ADMITTED FOR VALVE DYSFUNCTION, AND ON 9/10/1997, DR. EXPLANTED THIS VALVE DUE TO THROMBOSIS. THROMBUS WAS OBSERVED MAINLY IN THE RECESSED PIVOT AREAS OF THE POSTERIOR LEAFLET. INTRAOPERATIVELY, A VENT TUBE WAS INSERTED BETWEEN THE LEAFLETS, PRIOR TO EXPLANTING THIS VALVE. ANOTHER MANUFACTURER'S BIOPROSTHESIS WAS THEN IMPLANTED, AND THE PT'S POSTOPERATIVE HEALTH STATUS WAS REPORTED AS FAVORABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEFLON FIBER CUFF Implant MECHANICAL HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 29MT-103 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention