BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1

    MDR report key: 4182141 · Received October 17, 2014

    Report

    Report Number
    2025587-2014-00771
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    March 31, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCORRECTLY REPORTED AS AN ANNULOPLASTY RING. THE DEVICE INFORMATION HAS BEEN CORRECTED TO INDICATE THAT IT IS A SHUNT. PRODUCT ANALYSIS AND INVESTIGATION ARE ONGOING.

    Additional Manufacturer Narrative · 1

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

    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 1 YEAR POST IMPLANT OF THIS DEVICE, THE PATIENT CAME IN FOR A FOLLOW-UP AND THE PHYSICIAN NOTED THAT THE DEVICE WAS FRACTURED. THE PHYSICIAN NOTED THAT AFTER THE INITIAL IMPLANT OF THE RING A YEAR AGO, THE PATIENT WAS NOT VERY ACTIVE AND REMAINED IN A SITTING OR PRONE POSITION FOR A LONG PERIOD OF TIME. THE PHYSICIAN DID NOT FEEL THERE WAS A PRODUCT QUALITY ISSUE. THE PHYSICIAN EXPLANTED THE DEVICE AND REPLACED IT WITH ANOTHER DEVICE (UNKNOWN DEVICE). IT WAS NOT KNOWN IF THE DEVICE WOULD BE RETURNED FOR ANALYSIS. THERE WERE NO VISUAL IMAGES OR FILMS AVAILABLE THAT SHOWED THE BREAK.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A FRACTURE OF THIS ANNULOPLASTY RING WAS OBSERVED DURING THE PATIENT¿S ONE-YEAR POST-IMPLANT FOLLOW-UP. IT WAS REPORTED THAT THE PATIENT WAS MOSTLY INACTIVE FOR LONG PERIODS OF TIME IN SITTING OR PRONE POSITIONS, BUT THE PHYSICIAN DID NOT FEEL THERE WAS A QUALITY ISSUE WITH THE RING. THE RING WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER¿S DEVICE. IT WAS NOT KNOWN IF THIS DEVICE WOULD BE RETURNED FOR ANALYSIS. THERE WERE NO VISUAL IMAGES OR FILMS AVAILABLE THAT SHOWED THE BREAK. NO ADVERSE PATIENT EFFECTS WERE REPORTED PRIOR TO OR AFTER THE REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660175 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1 RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 25132-1 D13830

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention