BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 3140138 · Received May 31, 2013

    Report

    Report Number
    2134151-2013-00016
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 21, 2013
    Report Date
    August 15, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS SUMMARY: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE HISTOPATHOLOGICAL EVALUATION CONFIRMED THE CLINICAL DIAGNOSIS OF FIBRIN THROMBUS DEPOSITION. HOST PANNUS WAS PRESENT ON THE INFLOW AND OUTFLOW SEWING RING. THERE WAS NO EVIDENCE OF INFECTION IN THE TISSUE SECTIONS EXAMINED. THE LEAFLETS WERE FULLY MOBILE. THERE WERE NO VISUAL ANOMALIES OR DAMAGE NOTED ON THE CARBON SUBASSEMBLY. AFTER REMOVAL OF THE SEWING RING, THE SERIAL NUMBER WAS VERIFIED TO BE CORRECT. THE VALVE WAS INSPECTED AND FUNCTIONALLY TESTED PER MANUFACTURING PROCEDURES AND MET THE CURRENT PROCESS SPECIFICATIONS. THE CARBON COMPONENTS AND STIFFENING RING WERE DIMENSIONALLY INSPECTED. ALL DIMENSIONS MET THE ENGINEERING SPECIFICATIONS. THERE WAS NO EVIDENCE THAT THE VALVE FAILED TO MEET ITS PERFORMANCE SPECIFICATION. CONCLUSION: REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO THROMBUS. THIS FINDING IS GENERALLY CONSIDERED A PATIENT RELATED CONDITION. (B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO THROMBUS. THIS FINDING IS GENERALLY CONSIDERED A PATIENT RELATED CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS MECHANICAL VALVE, IMPLANTED 18 MONTHS, WAS EXPLANTED DUE TO THROMBUS WHICH CAUSED ONE LEAFLET TO BE STUCK IN THE CLOSED POSITION. AT REPLACEMENT, ONE DISC WAS COMPLETELY COVERED IN WHITE THROMBUS WHICH EXTENDED HALF WAY THROUGH THE ANNULAR AREA TO THE OTHER DISC, BUT DID NOT INVOLVE THE OTHER DISC. THERE WAS NO THROMBUS IN THE LEFT ATRIUM AND THE PATIENT WAS IN NORMAL SINUS RHYTHM THROUGHOUT. THE VALVE WAS REPLACED WITH ANOTHER ATS MECHANICAL VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241915 OPEN PIVOT MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 500DM31

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention