BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 4067669 · Received September 8, 2014

    Report

    Report Number
    2025587-2014-00633
    Event Type
    Death
    Date Received
    September 8, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION MADE TO MFR NAME, TO MEDTRONIC HEART VALVES DIVISION USER FACILITY REPORT NUMBER - (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE ALL LEAFLETS WERE STIFF DUE TO HOST TISSUE ON THE INFLOW AND OUTFLOW. A SMALL TEAR ALONG THE INFLOW MARGIN OF ATTACHMENT OF THE LEFT CUSP WAS CONSISTENT WITH A PUNCTURE OR LACERATION BY A SHARP INSTRUMENT SUCH AS FORCEPS RESULTING WITH A SMALL INTRACUSPAL HEMATOMA. THE EXPOSED TUNICA OF THE RIGHT AND NON-CORONARY CUSPS WAS INTACT. HOST TISSUE EXTENDED ON ALL COMMISSURES MAKING IT DIFFICULT TO DETERMINE THE CONDITION HOWEVER; THE EXPOSED AREAS SHOW THE COMMISSURES TO BE INTACT. TAN THROMBOTIC HOST TISSUE FILLED AND STIFFENED THE NON-CORONARY AND LEFT CUSPS ON THE OUTFLOW, WITH THROMBUS EXTENDING LONG THE LUNULA OF BOTH CUSPS ON THE INFLOW. TAN THROMBOTIC HOST TISSUE ALONG THE LUNULA OF THE LEFT CUSP ON THE INFLOW EXTENDED ACROSS THE SUPERIOR COAPTIVE AREA TO THE LUNULA OF THE RIGHT CUSP RESULTING WITH THE RIGHT CUSP ADHERED IN THE OPEN POSI TION. REMNANTS OF PANNUS LINED THE SEWING RING ON THE OUTFLOW ADJACENT TO THE LEFT AND RIGHT CUSPS WITHIN THE EXISTING PLEDGETS. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO THROMBUS AND HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT-RELATED CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATION IS IN PROCESS. ONCE THE EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH. THE PATIENT WAS ADMITTED FOR CONGESTIVE HEART FAILURE (CHF) AND ATRIAL ARRHYTHMIA. THE PATIENT¿S ECHOCARDIOGRAM SHOWED STENOSIS, THROMBUS, HIGH GRADIENTS, AND MODERATE MITRAL VALVE REGURGITATION. THE PATIENT WAS ADMITTED FOR VALVE EXPLANT AND WENT INTO CARDIOGENIC SHOCK WITH RESPIRATORY FAILURE. THE PATIENT WAS EMERGENTLY BROUGHT TO THE OPERATING ROOM, THE VALVE WAS EXPLANTED. UPON EXPLANT, THE VALVE APPEARED TO HAVE A GROWTH ON IT. THE VALVE WAS SENT TO HOSPITAL PATHOLOGY. THE HOSPITAL PATHOLOGY REPORT NOTED THAT THE VALVE LEAFLETS WERE PARTIALLY FUSED AND CONTAINED NODULAR APPARENT VEGETATION. THE GROWTH WAS NOTED TO BE THROMBUS AND THE CULTURES WERE NEGATIVE FOR ENDOCARDITIS. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A MEDTRONIC MECHANICAL VALVE. THE PATIENT HAS IMPROVED HOWEVER IS STILL IN CRITICAL CONDITION WITH A PACKED CHEST WITH PLANS TO CLOSE THE CHEST IN THE NEAR FUTURE. IT WAS NOTED THAT THE PATIENT STATED THEIR SHORTNESS OF BREATH STARTED ONE WEEK AFTER IMPLANT OF THE BIOPROSTHETIC VALVE AND HAD NOT IMPROVED DESPITE INCREASED DOSAGE OF FUROSEMIDE PRIOR TO PRESENTING TO THE HOSPITAL. PATIENT HAS A KNOWN HISTORY OF ATRIAL FIBRILLATION, GERD, AND RECEIVING ANTICOAGULATION THERAPY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT TWO WEEKS FOLLOWING IMPLANT OF THE MECHANICAL VALVE, THE PATIENT DEVELOPED SEPSIS AND DIED. THE CAUSE OF DEATH WAS REPORTED TO BE RESPIRATORY FAILURE. IT WAS REPORTED THAT AN ECHOCARDIOGRAM VERIFIED THAT THE VALVE WAS WORKING PROPERLY; THERE WAS NO ALLEGATION THAT THE DEATH WAS RELATED TO THE VALVE OR ITS FUNCTION. AN AUTOPSY WAS NOT PERFORMED, AND THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548220 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| R