BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD CUFF

    MDR report key: 152819 · Received February 27, 1998

    Report

    Report Number
    2648612-1998-00002
    Event Type
    Injury
    Date Received
    February 27, 1998
    Date of Event
    February 12, 1998
    Report Date
    February 27, 1998
    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

    DESCRIPTION OF EVENT - ON 08 DECEMBER, 1993, DR. IMPLANTED A 23 MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 23A-101). APPROXIMATELY FOUR YEARS POSTOPERATIVELY, ON 12 FEBRUARY, 1998, DR. EXPLANTED THIS VALVE DUE TO THROMBUS WHICH HAD CAUSED ONE LEAFLET TO BE BLOCKED. ANOTHER MFR'S 23 MM HEART VALVE WAS THEN IMPLANTED, AND THE PT'S POSTOPERATIVE HEALTH STATUS WAS REPORTED AS STABLE. RESULTS OF INVESTIGATION - THE VALVE WAS REC'D IN THE ST. JUDE MEDICAL HEART VALVE DIV FER ANALYSIS LABORATORY IN A ST. JUDE MEDICAL PRODUCT RETURN KIT, SUBMERGED IN A LIQUID SOLUTION. THE OUTER PORTION OF THE SEWING CUFF HAD BEEN CUT OFF, AND WAS RETURNED FLOATING IN THE SOLUTION. THE WINDING SUTURES WERE THEREFORE EXPOSED, AND THE INNER PORTION OF THE SEWING CUFF, WHICH WAS BROWNISH-GRAY IN COLOR AND CONTAINED SUTURES, REMAINED ONT EH ORIFICE. LARGE AMOUNTS OF BROWNISH TISSUE WERE OBSERVED IN THE RECESSED PIVOT AREAS AND ON THE OUTSIDE AND TOP SURFACES OF THE PIVOT GUARDS. SOME WHITISH TISSUE WAS ALSO OBSERVED ON THE PIVOT GUARDS. BOTHE LEAFLETS DID NOT OPEN COMPLETELY, MOST LIKELY DUE TO THE PRESENCE OF THE TISSUE IN THE RCESSED PIVOT AREAS IMPEDING NORMAL MOBILITY. THE VALVE WAS CHEMICALLY STERILIZED AND FORWARDED TO AN INDEPENDENT PATHOLOGIST FOR GROSS MORPHOLOGICAL EXAMINATION. DR. STATED THAT AT THE TIME OF HIS EXAMINATION, LARGE AMOUNTS OF THROMBUS AND PANNUS FORMATION AT DIFFERENT SITES ESSENTIALLY IMMOBILIZED BOTH LEAFLETS. THE FIBROUS TISSUE OBSERVED ON THE PIVOT GUARDS WAS IDENTIFIED AS MATURE COLLAGEN, WITH SMALL NUMBERS OF CELL NUCLEI AND LARGER PORTIONS OF LAYERED YOUND CONNECTIVE TISSUE REFLECTING AN ONGOING HEALING PROCESS. THE BULK OF THIS FIBROUS TISSUE WAS YOUNG CELLULAR TISSUE WITH SOME CELLS WHICH WERE MYOFIBROBLASTIC IN A MYXOID STROMA. SMALL FOCI OF PERFORMED ELASTIC TISSUE WERE PRESENT WHICH WOULD REFLECT NATIVE TISSUE FROM THE SITE OF IMPLANTATION. TISSUE OBTAINED FROM THE RECESSED PIVOT AREAS WAS IDENTIFIED AS ALTERED FIBRIN WITH ACCUMULATIONS OF FRESH BLOOD AND WAS CONSIDERED TO BE AN EX VIVO EVENT. THIS ORGANIZED OR ORGANIZING THROMBUS ESSENTIALLY IMMOBILIZED BOTH LEAFLETS. NO INFLAMMATION WAS DETECTED, AND GRAM STAIN WAS NEGATIVE. THE VALVE WAS THEN CLEANED, AND THE REMAINDER OF THE SEWING CUFF WAS REMOVED. THE VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON THE SURFACES OF THE LEAFLETS AND ORIFICE. A SMALL CHIP WAS DETECTED ON THE LEFT OUTFLOW RIM OF THE ORIFICE, WHICH WAS MOST LIKELY CAUSED AT EXPLANT. THIS CHIP WAS NOT PRESENT AT THE TIME OF MFR AND INSPECTION, AS EVIDENCED BY SIGNATURES AND DATES ON THE VALVE'S DEVICE HISTORY RECORD. THE REMAINDER OF THE ORIFICE, AS WELL AS BOTHE LEAFLETS, WERE FOUND TO BE UNREMARKABLE. THE VALVE WAS THEN FORWARDED FOR PERFORMANCE TESTING. THE RESULTS OF THE PULSE DUPLICATOR TESTING INDICATED THE VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED THE VALVE OPERATED SATISFACTORILY, WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTION.

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO THROMBOSIS WHICH HAD CAUSED ONE LEAFLET TO BE BLOCKED.

    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. 23A-101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention