BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 2690886 · Received August 10, 2012

    Report

    Report Number
    2135394-2012-00006
    Event Type
    Death
    Date Received
    August 10, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    MEDTRONIC AFT
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. BASED ON THE REPORTED INFORMATION, REDUCED PERFORMANCE OF THE VALVE AND THE CAUSE OF DEATH WERE ATTRIBUTED TO PANNUS (TISSUE OVERGROWTH) AND THROMBUS. THESE FINDINGS GENERALLY ARE CONSIDERED PATIENT-RELATED CONDITIONS. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    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 A PHYSICIAN CONTACTED MEDTRONIC TECHNICAL SERVICES FOR A REVIEW OF THE FUNCTIONALITY OF A MECHANICAL HEART VALVE THAT HAD BEEN IMPLANTED FOR APPROXIMATELY ELEVEN YEARS IN A PATIENT DIAGNOSED WITH AORTIC MARFAN'S SYNDROME. THE PHYSICIAN QUESTIONED WHETHER THE VALVE'S DISC WAS CLOSING PROPERLY AND IF THERE WAS AN INDICATION OF A FRACTURE. THE TECHNICIAN'S REVIEW OF SUBMITTED IMAGES INDICATED THERE WAS AN ISSUE WITH THE DISC CLOSURE BUT NO EVIDENCE OF A FRACTURE. SUBSEQUENTLY, IT WAS REPORTED THE PATIENT PASSED AWAY THE DAY OF THE REVIEW OF THE VALVE'S FUNCTIONALITY. THE CAUSE OF DEATH WAS REPORTED AS NON-STRUCTURAL VALVE DYSFUNCTION DUE TO PANNUS (TISSUE OVERGROWTH) AND THROMBUS. THE VALVE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HALL PROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC AFT A7700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death