Additional Manufacturer Narrative · 1
DESCRIPTION OF EVENT: ON 01 APRIL, 1998, PROFESSOR IMPLANTED A 19 MM AORTIC ST JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES (MODEL 19AHPJ-505). PT HAD A HEAVILY CALCIFIED ANNULUS THAT REQUIRED DEBRIDEMENT. ACCORDING TO IMPLANT OPERATIVE REPORT, THIS VALVE WAS IMPLANTED WITH "TYCRON 2/0 FIXED ON TEFLON FELT, PLACED IN INTRA-ANNULAR POSITION". ON 10 APRIL, 1998, PROFESSOR EXPLANTED THIS VALVE DUE TO AN IMPEDED LEAFLET. AT EXPLANT, ONE LEAFLET WAS NOTED TO BE IMMOBILE DUE TO A FIBRINOUS DEPOSIT AND NO THROMBUS UNDERNEATH. A "FOLD" WAS OBSERVED UNDER IMPEDED LEAFLET FOLLOWING EXPLANT, WHICH HAMPERED THE OPENING OF LEAFLET. OTHER LEAFLET WAS ABLE TO OPEN, BUT NOT COMPLETELY CLOSE. FOLLOWING EXPLANT OF THIS VALVE, A 19 MM AORTIC ST JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WAS IMPLANTED. PT'S POSTOPERATIVE HEALTH STATUS WAS REPORTED AS STABLE. RESULTS OF INVESTIGATION: VALVE WAS REC'D IN THE ST JUDE MEDICAL HEART VALVE DIVISION FOR ANALYSIS LABORATORY IN A SMALL SPECIMEN CONTAINER, SUBMERGED IN A LIQUID SOLUTION. SEWING CUFF WAS TANNISH IN COLOR, AND CONTAINED A SMALL AMOUNT OF BROWNISH SUBSTANCE. BOTH LEAFLETS OPENED AND CLOSED COMPLETELY; HOWEVER, ONE EXHIBITED SLIGHT RESTRICTION TO MOBILITY DUE TO THE PRESENCE OF A MASS OF WHITISH-GRAY TISSUE IN ONE OF THE ASSOCIATED RECESSED PIVOT AREAS. VALVE WAS CHEMICALLY STERILIZED AND SENT TO THE ST JUDE MEDICAL WOODRIDGE FACILITY FOR X-RAY TO EVALUATE ROTATION MECHANISM. ROTATION MECHANISM EXHIBITED NO ABNORMALITIES. ROTATION MECHANISM WAS THEN TESTED USING A CHATILLON DIGITAL TORQUE GUAGE. PER DEVICE SPECIFICATION FOR ST JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES, BOTH CLOCKWISE AND COUNTERCLOCKWISE TORQUE VALUES WERE WITHIN MFG SPECIFICATIONS. VALVE WAS THEN FORWARDED TO DR AN INDEPENDENT PATHOLOGIST AT THE CENTER, FOR GROSS MORPHOLOGICAL EXAMINATION. DR STATED THAT AT THE TIME OF HIS EXAMINATION, A SMALL FRAGMENT OF SLIGHTLY DISCOLORED FIBRIN WAS PRESENT ON THE OUTERMOST ASPECT OF THE SEWING CUFF, REMOTE FROM ANY FUNCTIONAL PART OF THE VALVE. ONE LEAFLET EXHIBITED NORMAL MOBILITY, AND THE OTHER LEAFLET EXHIBITED SLIGHT RESTRICTION TO MOBILITY. DR STATED THAT THIS WAS MOST LIKELY DUE TO MATERIAL IN ONE OF ASSOCIATED RECESSED PIVOT AREAS; HOWEVER, THIS MATERIAL WAS INACCESSIBLE FOR MICROSCOPIC EXAMINATION DUE TO THE FACT IT COULD NOT BE REMOVED WITH THE LEAFLETS HOUSED IN THE ORIFICE, THEREBY ENTRAPPING THE MATERIAL IN THE RECESSED PIVOT AREA. AT THIS POINT, VALVE WAS RETURNED TO ST JUDE MEDICAL HEART VALVE DIVISION. AT THE REQUEST OF DR LEAFLETS WERE REMOVED FROM ORIFICE IN ORDER TO ALLOW BETTER VISUALIZATION OF RECESSED PIVOT AREAS AND PREVIOUSLY MENTIONED MATERIAL CAUSING IMPEDED LEAFLET. DUE TO FACT VALVE WAS DISASSEMBLED, PERFORMANCE TESTING COULD NO LONGER BE PERFORMED ON THIS VALVE. HOWEVER, REVIEW OF THE VALVE'S DEVICE HISTORY RECORD INDICATED THE VALVE PERFORMED IN ACCORDANCE WITH ST JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. IN ORDER TO REMOVE THE LEAFLETS, THE SEWING CUFF WAS REMOVED TO ALLOW THE ORIFIC TO BE TEMPORARILY SPREAD/DISTORTED. THE ORIFICE, THE REMOVED LEAFLETS AND SEWING CUFF, AND ASSOCIATED MATERIALS WERE RETURNED TO DR. THE MATERIAL PREVIOUSLY LODGED IN THE RECESSED PIVOT AREA WAS OBSERVED TO BE FLOATING FREELY IN THE FORMALIN. THIS SMALL 3X2X1 MM FRAGMENT OF MATERIAL WAS IDENTIFIED AS FIBRIN WITH ENTRAPPED, PARTIALLY INTACT AND PARTIALLY EARLY DEGENERATING BLOOD CELLS. SCATTERED NUCLEI OF WHITE BLOOD CELLS WERE PRESENT, SOME DISPLAYING KARYOLYSIS. DR CONCLUDED THAT THE RECENT FIBRIN THROMBUS WITHOUT SPECIFIC ORGANIZATION OR INFLAMMATION WAS MOST LIKELY THE CAUSE OF THE LEAFLET IMPEDANCE. THE BROWNISH SUBSTANCE OBSERVED ON THE OUTERMOST ASPECTS OF THE SEWING CUFF WAS IDENTIFIED AS ANTICIPATED DISCOLORATION FROM BLOOD STAINING. THE SEWING CUFF WAS FREE OF ANY SORT OF TISSUE REACTION. THE VALVE COMPONENTS AND DETACHED SEWING CUFF WERE RETURNED TO ST. JUDE MEDICAL HEART VALVE DIVISION. DISASSEMBLED VALVE WAS CLEANED & VISUALLY EXAMINED AT 10X MAGNIFICATION FOR ANY ANOMALIES ON SURFACES OF LEAFLETS & ORIFICE. ORIFICE LEAFLETS WERE FOUND TO BE UNREMARKABLE. VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG & INSPECTION OPERATION WAS FOLLOWED BY APPROPRIATE SIGNATURE & DATE, INDICATING THAT PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR MFG & INSPECTION OF THIS VALVE & ITS PACKAGING WAS FOLLOWED BY APRPOPRIATE SIGNATURE AND DATE. THIS VALVE FUNCTIONED IN ACCORDANCE WITH ALL PERFORMANCE TESTS & WAS VERIFIED TO BE DIMENSIONALLY WITHIN SPECIFICATIONS AT TIME OF MFR. CONCLUSION: INFO REVIEWED FROM VALVE'S DEVICE HISTORY RECORD & ADDITIONAL TESTING PERFORMED THROUGH THE FER ANALYSIS LAB INDICATED VALVE COMPLIED WITH ST. JUDE MEDICAL SEPCIFICATIONS AT TIME OF MFR. RESULTS OF THIS INVESTIGATION INDICATED LEAFLET IMPEDANCE WAS MOST LIKELY DUE TO PRESENCE OF A SMALL FRAGMENT OF RECENT FIBRIN THROMBUS LODGED IN ONE OF RECESSED PIVOT AREAS. THIS WAS SUPPORTED BY DR'S EXAMINATION, AS WELL AS FACT THAT LEAFLET ASSOCIATED WITH THIS RECESSED PIVOT AREA CONTAINING FIBRIN THROMBUS EXHIBITED SLIGHT RESTRICTION TO MOBILITY AT TIME VALV WAS RETURNED TO ST. JUDE MEDICAL HEART VALVE DIVISION FOR ANALYSIS. AS PREVIOUSLY MENTIONED, THE LEAFLET IMPEDANCE WAS NOT DUE TO AN INTRINSIC VALVE DEFECT, AS SUPPORTED BY THE FACT THIS VALVE PERFORMED IN ACCORDANCE TO ALL SPECIFICATIONS, AND WAS VERIFIED TO BE DIMENSIONALLY WITHIN DOCUMENTED SPECIFICATIONS, AT THE TIME OF MFR. IN ORDER TO REMOVE LEAFLETS, SEWING CUFF WAS REMOVED TO ALLOW ORIFICE TO BE TEMPORARILY SPREAD/DISTORTED. ORIFICE, REMOVED LEAFLETS AND SEWING CUFF, AND ASSOCIATED MATERIALS WERE RETURNED TO DR FOR FURTHER EXAMINATION. MATERIAL PREVIOUSLY LODGED IN RECESSED PIVOT AREA WAS OBSERVED TO BE FLOATING FREELY IN FORMALIN. THIS SMALL 3X2X1 MM FRAGMENT OF MATERIAL WAS IDENTIFIED AS FIBRIN WITH ENTRAPPED, PARTIALLY INTACT AND PARTIALLY EARLY DEGENERATING BLOOD CELLS. SCATTERED NUCLEI OF WHITE BLOOD