BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD CUFF

    MDR report key: 160333 · Received April 2, 1998

    Report

    Report Number
    2648612-1998-00005
    Event Type
    Injury
    Date Received
    April 2, 1998
    Date of Event
    March 9, 1998
    Report Date
    April 2, 1998
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF INFO WRITTEN REPORT (FER FORM) BASED ON PHONE CONVERSATION BETWEEN ST. JUDE MEDICAL HEART VALVE DIV FER COORDINATOR, AND CLINICAL MANAGER, OR ON 3/9/1998. DESCRIPTION OF EVENT ON 7/20/1990, DR. IMPLANTED 19 MM AORTIC ST. JUDE MEDICAL MECHANICAL HEART VALVE (MODEL 19A-101). ON 3/6/1998, DR. EXPLANTED THIS VALVE DUE TO THROMBUS, STATING THAT VALVE WAS "INSUFFICIENT AND STENOTIC". BLOOD CULTURES WERE OBTAINED AT HOSP. PT'S POSTOPERATIVE HEALTH STATUS WAS REPORTED AS STABLE. RESULTS OF INVESTIGATION VALVE WAS RECEIVE IN ST. JUDE MEDICAL HEART VALVE DIV FER ANALYSIS LABORATORY IN ST. JUDE MEDICAL PRODUCT RETURN KIT, SUBMERGED IN LIQUID SOLUTION. OUTER PORTION OF SEWING CUFF HAD PREVIOUSLY BEEN CUT OFF, AND WAS RETURNED FLOATING IN FORMALIN SOLUTION. INNER PORTION OF SEWING CUFF, INCLUDING UNDERLYING WINDING SUTURES, REMAINED ATTACHED TO CARBON ORIFICE. BOTH LEAFLETS WERE RETURNED HOUSED IN ORIFICE, EXHIBITING RESTRICTED LEAFLET MOBILITY. THIS RESTRICTION WAS MOST LIKELY DUE TO PRESENCE OF TANNISH TISSUE, WHICH WAS OBSERVED IN ALL FOUR RECESSED PIVOT AREAS. VALVE WAS CHEMICALLY STERILIZED AND FORWARDED TO INDEPENDENT PATHOLOGIST FOR GROSS MORPHOLOGICAL EXAMINATION. DR. STATED THAT AT TIME OF HIS EXAMINATION, SMALL AMOUNTS OF SOFT FIBROUS AND/OR FIBRINOUS TISSUE WERE OBSERVED NEAR THE PIVOT AREAS. AS PREVIOUSLY MENTIONED, THIS MATERIAL APPEARED TO CAUSE SOME RESTRICTION TO FULL MOVEMENT OF BOTH LEAFLETS. THIS TISSUE WAS DETERMINED TO BE PRIMARILY RED BLOOD CELSS WITH SOME APPARENTLY ENTRAPPED LEUKOCYTES THAT WERE NOT REMARKABLE. A FEW STRANDS OF ALTERED FIBRIN WERE ALSO PRESENT. NO INFLAMMATION OR MICROORGANISMS WERE IDENTIFIED. DR. CONCLUDED THAT RESTRICTED LEAFLET MOTION WAS MOST LIKELY DUE TO THROMBOTIC MATERIAL OF RECENT ORIGIN. VALVE WAS THEN CLEANED, AND INNER PORTION OF SEWING CUFF WAS REMOVED. VALVE WAS THEN VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON SURFACES OF LEAFLETS AND ORIFICE. BOTH LEAFLETS EXHIBITED NORMAL MOBILITY AFTER CLEANING. ORIFICE AND LEAFLETS WERE FOUND TO BE UNREMARKABLE. VALVE WAS THEN DISASSEMBLED AND FORWARDED FOR PERFORMANCE TESTING. RESULTS OF PULSE DUPLICATOR TESTING INDICATED VALVE HAD NO ABNORMAL OPERATION. FLOW AND PRESSURE TRACES INDICATED VALVE OPERATED SATISFACTORILY, WITHOUT LEAFLET OR HYDRODYNAMIC MALFUNCTIONS. FUNCTIONAL LEAKAGE TESTING WAS PEFORMED, AND VALVE MET ALL OF ST. JUDE MEDICAL'S SPECIFICATIONS. VALVE WAS THEN DISASSEMBLED FOR DIMENSIONAL INSPECTION. LEAFLET AND ORIFICE DIMENSIONS WERE INSPECTED AND VERIFIED TO BE WITHIN ST. JUDE MEDICAL'S SPECIFICATIONS. VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY APPROPRIATE SIGNATURE AND DATE, INDICATING THAT PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR MFG AND INSPECTION OF THIS VALVE AND ITS PACKAGING WAS FOLLOWED BY APPROPRIATE SIGNATURE AND DATE.

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO THROMBUS. THE SURGEON STATED THE VALVE WAS INSUFFICIENT AND STENOTIC.

    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. 19A-101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention